11,908 Senior Quality Engineer jobs in India

**Key responsibilities**
**Maintenance**
Responsible for the implementation and maintenance of quality standards within manufacturing processes. Ensure alignment with the requirements of the Driveline Excellence System.
**Process Design**
Ensure manufacturing processes and related documentation conforms to specified Process Flow, PFMEA, and Control Plan requirements.
**Quality Testing**
Develop and initiate methods, procedures, and embedded tests for inspection, testing, and evaluation of manufactured products. Maintain related documentation and records.
**Quality Testing Design**
Confirm that final inspection/EOL tests prevent non-conforming parts from leaving the plant and coordinate containment and firewall activities.
**Operational Compliance**
Perform manufacturing process audits to assess quality capability of the processes against established limits and specifications. Provide additional input for process control and initiate a reaction plan for characteristics that are either not statistically capable or are unstable.
**Quality Management System**
Carry out a range of quality management activities under the guidance of senior colleagues to contribute to the identification and evaluation of current policies and business processes that are in the scope of the quality management system (QMS) and to support the design, development, and documentation of new policies, procedures, and business processes.
**Improvement/Innovation**
Ensure relevant lessons learned are implemented and countermeasures are horizontally deployed as required.
**Document Preparation**
Organize and prepare complex documents using a variety of applications for technology devices, such as standard office software. Also responsible for gathering and summarizing data for special reports.
**Performance Management**
Undertake training when identified to improve business capability and allow for changes in technology and quality requirements. Instigate quality improvements in production area and strive for continuous improvement.
**Skills**
**Planning and Organizing**
Works without supervision and provides technical guidance when required on planning, organizing, prioritizing and overseeing activities to efficiently meet business objectives. **Policy and procedures**
Works without supervision and provides technical guidance when required on developing, monitoring, interpreting and understanding policies and procedures, while making sure they match organizational strategies and objectives.
**Compliance Management**
Works without supervision and provides technical guidance when required on achieving full compliance with applicable rules and regulations in management and/or operations.
**Policy and Regulation**
Works without supervision and provides technical guidance when required on interpreting and applying knowledge of laws, regulations and policies in area of expertise.
**Review and Reporting**
Works without supervision and provides technical guidance when required on reviewing and creating relevant, lucid and effective reports.
**Verbal Communication**
Uses clear and effective verbal communications skills without supervision and provides technical guidance when required on expressing ideas, requesting actions and formulating plans or policies.
**Health and Safety**
Manages and applies safe systems of work without supervision and provides technical guidance when required.
**Risk Management**
Identifies, assesses, prioritizes and manages risks without supervision and provides technical guidance when required.
**Education**
Bachelor's Degree or Equivalent Level
**Experience**
4-5 years minimum.
GKN Driveline provides equal employment and affirmative action opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, age, genetic information, pregnancy, or disability.

Company Description

TAK Automation, accredited with ISO 9001–2015, is based in Coimbatore, India and specializes in precision machined products made from ferrous and nonferrous metals, as well as aluminum. The company is led by highly qualified professionals with extensive experience in the fields of aluminum and steel foundry, CNC machining, casting, forging, welding, heat treatment, special processes, and R&D. TAK Automation is dedicated to delivering high-quality products and excelling in customer service.

Role Description

This is a full-time, on-site role for a Manufacturing Quality Engineer located in Coimbatore. The Manufacturing Quality Engineer will be responsible for ensuring quality control throughout the manufacturing process, conducting quality audits, and implementing quality management systems. The role includes tasks such as quality assurance, quality engineering, and maintaining compliance with industry standards.

Qualifications

• Experience in Quality Control and Quality Assurance
• Skills in Quality Engineering and Quality Management
• Proficiency in Quality Auditing procedures
• Strong problem-solving and analytical skills
• Excellent written and verbal communication skills
• Ability to work independently and collaboratively
• Experience in the manufacturing industry is a plus
• Bachelor's degree in Engineering or related field

Key Roles and Responsibilities

1. Quality System Development and Maintenance

The quality engineer is responsible for developing, implementing, and maintaining the Quality Management System (QMS). This includes establishing and documenting procedures, work instructions, and standards that align with industry certifications like ISO 9001 or IATF 16949. They ensure the machine shop is in compliance with all relevant regulations and customer requirements.

2. Quality Planning and Process Control

They play a central role in the planning phase of production. This includes:

• Interpreting engineering drawings and GD&T (Geometric Dimensioning and Tolerancing): Translating design specifications into actionable quality control plans.
• Developing inspection plans: Creating detailed plans for what to inspect, when to inspect it, and which tools to use at each stage (e.g., raw material, in-process, and final inspection).
• Implementing Statistical Process Control (SPC): Using statistical methods and control charts to monitor key process variables (like cutting speed and feed rate) to ensure the process remains stable and consistent.
• Conducting First Article Inspection (FAI): Performing a thorough inspection of the first part produced in a new production run to ensure it meets all specifications before mass production begins.

3. Root Cause Analysis and Corrective Actions

When a defect or non-conformance occurs, the quality engineer leads the investigation. They:

• Conduct root cause analysis: Use problem-solving methodologies (like the 5 Whys or Fishbone diagrams) to identify the underlying cause of the issue.
• Implement Corrective and Preventive Actions (CAPA): Develop and implement solutions to fix the current problem and prevent it from recurring in the future.
• Manage non-conforming materials: Ensure that defective parts are properly quarantined, dispositioned, and accounted for to prevent them from reaching the customer.

4. Inspection and Metrology

A core responsibility involves the hands-on inspection of parts. This requires a deep understanding of metrology and proficiency with various measurement tools:

• Manual tools: Using calipers, micrometers, and bore gauges for basic measurements.
• Advanced equipment: Operating and programming sophisticated machinery like a CMM (Coordinate Measuring Machine) to measure complex geometries and tight tolerances.
• Surface finish analysis: Using profilometers to ensure the surface roughness of parts meets specifications.

5. Continuous Improvement

The quality engineer is a champion of continuous improvement. They analyze quality data, identify trends, and lead initiatives to enhance product quality and process efficiency. This can involve:

• Data analysis: Using software to analyze quality metrics, such as scrap rates, first-pass yield, and customer complaints.
• Leading improvement projects: Heading projects focused on reducing defects, improving process capability, and optimizing production workflows.
• Training: Training machine operators and other staff on new quality procedures, standards, and the proper use of inspection equipment.

Industry

• Manufacturing

Company DescriptionTAK Automation, accredited with ISO 9001–2015, is based in Coimbatore, India and specializes in precision machined products made from ferrous and nonferrous metals, as well as aluminum. The company is led by highly qualified professionals with extensive experience in the fields of aluminum and steel foundry, CNC machining, casting, forging, welding, heat treatment, special processes, and R&D. TAK Automation is dedicated to delivering high-quality products and excelling in customer service.Role DescriptionThis is a full-time, on-site role for a Manufacturing Quality Engineer located in Coimbatore. The Manufacturing Quality Engineer will be responsible for ensuring quality control throughout the manufacturing process, conducting quality audits, and implementing quality management systems. The role includes tasks such as quality assurance, quality engineering, and maintaining compliance with industry standards.QualificationsExperience in Quality Control and Quality AssuranceSkills in Quality Engineering and Quality ManagementProficiency in Quality Auditing proceduresStrong problem-solving and analytical skillsExcellent written and verbal communication skillsAbility to work independently and collaborativelyExperience in the manufacturing industry is a plusBachelor's degree in Engineering or related fieldKey Roles and Responsibilities1. Quality System Development and MaintenanceThe quality engineer is responsible for developing, implementing, and maintaining the Quality Management System (QMS). This includes establishing and documenting procedures, work instructions, and standards that align with industry certifications like ISO 9001 or IATF 16949. They ensure the machine shop is in compliance with all relevant regulations and customer requirements.2. Quality Planning and Process ControlThey play a central role in the planning phase of production. This includes:Interpreting engineering drawings and GD&T (Geometric Dimensioning and Tolerancing): Translating design specifications into actionable quality control plans.Developing inspection plans: Creating detailed plans for what to inspect, when to inspect it, and which tools to use at each stage (e.g., raw material, in-process, and final inspection).Implementing Statistical Process Control (SPC): Using statistical methods and control charts to monitor key process variables (like cutting speed and feed rate) to ensure the process remains stable and consistent.Conducting First Article Inspection (FAI): Performing a thorough inspection of the first part produced in a new production run to ensure it meets all specifications before mass production begins.3. Root Cause Analysis and Corrective ActionsWhen a defect or non-conformance occurs, the quality engineer leads the investigation. They:Conduct root cause analysis: Use problem-solving methodologies (like the 5 Whys or Fishbone diagrams) to identify the underlying cause of the issue.Implement Corrective and Preventive Actions (CAPA): Develop and implement solutions to fix the current problem and prevent it from recurring in the future.Manage non-conforming materials: Ensure that defective parts are properly quarantined, dispositioned, and accounted for to prevent them from reaching the customer.4. Inspection and MetrologyA core responsibility involves the hands-on inspection of parts. This requires a deep understanding of metrology and proficiency with various measurement tools:Manual tools: Using calipers, micrometers, and bore gauges for basic measurements.Advanced equipment: Operating and programming sophisticated machinery like a CMM (Coordinate Measuring Machine) to measure complex geometries and tight tolerances.Surface finish analysis: Using profilometers to ensure the surface roughness of parts meets specifications.5. Continuous ImprovementThe quality engineer is a champion of continuous improvement. They analyze quality data, identify trends, and lead initiatives to enhance product quality and process efficiency. This can involve:Data analysis: Using software to analyze quality metrics, such as scrap rates, first-pass yield, and customer complaints.Leading improvement projects: Heading projects focused on reducing defects, improving process capability, and optimizing production workflows.Training: Training machine operators and other staff on new quality procedures, standards, and the proper use of inspection equipment.IndustryManufacturing

Company Description

TAK Automation, accredited with ISO 9001–2015, is based in Coimbatore, India and specializes in precision machined products made from ferrous and nonferrous metals, as well as aluminum. The company is led by highly qualified professionals with extensive experience in the fields of aluminum and steel foundry, CNC machining, casting, forging, welding, heat treatment, special processes, and R&D. TAK Automation is dedicated to delivering high-quality products and excelling in customer service.

Role Description

This is a full-time, on-site role for a Manufacturing Quality Engineer located in Coimbatore. The Manufacturing Quality Engineer will be responsible for ensuring quality control throughout the manufacturing process, conducting quality audits, and implementing quality management systems. The role includes tasks such as quality assurance, quality engineering, and maintaining compliance with industry standards.

Qualifications

• Experience in Quality Control and Quality Assurance
• Skills in Quality Engineering and Quality Management
• Proficiency in Quality Auditing procedures
• Strong problem-solving and analytical skills
• Excellent written and verbal communication skills
• Ability to work independently and collaboratively
• Experience in the manufacturing industry is a plus
• Bachelor's degree in Engineering or related field

Key Roles and Responsibilities

1. Quality System Development and Maintenance

The quality engineer is responsible for developing, implementing, and maintaining the Quality Management System (QMS). This includes establishing and documenting procedures, work instructions, and standards that align with industry certifications like ISO 9001 or IATF 16949. They ensure the machine shop is in compliance with all relevant regulations and customer requirements.

2. Quality Planning and Process Control

They play a central role in the planning phase of production. This includes:

• Interpreting engineering drawings and GD&T (Geometric Dimensioning and Tolerancing): Translating design specifications into actionable quality control plans.
• Developing inspection plans: Creating detailed plans for what to inspect, when to inspect it, and which tools to use at each stage (e.g., raw material, in-process, and final inspection).
• Implementing Statistical Process Control (SPC): Using statistical methods and control charts to monitor key process variables (like cutting speed and feed rate) to ensure the process remains stable and consistent.
• Conducting First Article Inspection (FAI): Performing a thorough inspection of the first part produced in a new production run to ensure it meets all specifications before mass production begins.

3. Root Cause Analysis and Corrective Actions

When a defect or non-conformance occurs, the quality engineer leads the investigation. They:

• Conduct root cause analysis: Use problem-solving methodologies (like the 5 Whys or Fishbone diagrams) to identify the underlying cause of the issue.
• Implement Corrective and Preventive Actions (CAPA): Develop and implement solutions to fix the current problem and prevent it from recurring in the future.
• Manage non-conforming materials: Ensure that defective parts are properly quarantined, dispositioned, and accounted for to prevent them from reaching the customer.

4. Inspection and Metrology

A core responsibility involves the hands-on inspection of parts. This requires a deep understanding of metrology and proficiency with various measurement tools:

• Manual tools: Using calipers, micrometers, and bore gauges for basic measurements.
• Advanced equipment: Operating and programming sophisticated machinery like a CMM (Coordinate Measuring Machine) to measure complex geometries and tight tolerances.
• Surface finish analysis: Using profilometers to ensure the surface roughness of parts meets specifications.

5. Continuous Improvement

The quality engineer is a champion of continuous improvement. They analyze quality data, identify trends, and lead initiatives to enhance product quality and process efficiency. This can involve:

• Data analysis: Using software to analyze quality metrics, such as scrap rates, first-pass yield, and customer complaints.
• Leading improvement projects: Heading projects focused on reducing defects, improving process capability, and optimizing production workflows.
• Training: Training machine operators and other staff on new quality procedures, standards, and the proper use of inspection equipment.

Industry

• Manufacturing

Key responsibilities

Maintenance

Responsible for the implementation and maintenance of quality standards within manufacturing processes. Ensure alignment with the requirements of the Driveline Excellence System.

Process Design

Ensure manufacturing processes and related documentation conforms to specified Process Flow, PFMEA, and Control Plan requirements.

Quality Testing

Develop and initiate methods, procedures, and embedded tests for inspection, testing, and evaluation of manufactured products. Maintain related documentation and records.

Quality Testing Design

Confirm that final inspection/EOL tests prevent non-conforming parts from leaving the plant and coordinate containment and firewall activities.

Operational Compliance

Perform manufacturing process audits to assess quality capability of the processes against established limits and specifications. Provide additional input for process control and initiate a reaction plan for characteristics that are either not statistically capable or are unstable.

Quality Management System

Carry out a range of quality management activities under the guidance of senior colleagues to contribute to the identification and evaluation of current policies and business processes that are in the scope of the quality management system (QMS) and to support the design, development, and documentation of new policies, procedures, and business processes.

Improvement/Innovation

Ensure relevant lessons learned are implemented and countermeasures are horizontally deployed as required.

Document Preparation

Organize and prepare complex documents using a variety of applications for technology devices, such as standard office software. Also responsible for gathering and summarizing data for special reports.

Performance Management

Undertake training when identified to improve business capability and allow for changes in technology and quality requirements. Instigate quality improvements in production area and strive for continuous improvement.

Skills

Planning and Organizing

Works without supervision and provides technical guidance when required on planning, organizing, prioritizing and overseeing activities to efficiently meet business objectives. Policy and procedures

Works without supervision and provides technical guidance when required on developing, monitoring, interpreting and understanding policies and procedures, while making sure they match organizational strategies and objectives.

Compliance Management

Works without supervision and provides technical guidance when required on achieving full compliance with applicable rules and regulations in management and/or operations.

Policy and Regulation

Works without supervision and provides technical guidance when required on interpreting and applying knowledge of laws, regulations and policies in area of expertise.

Review and Reporting

Works without supervision and provides technical guidance when required on reviewing and creating relevant, lucid and effective reports.

Verbal Communication

Uses clear and effective verbal communications skills without supervision and provides technical guidance when required on expressing ideas, requesting actions and formulating plans or policies.

Health and Safety

Manages and applies safe systems of work without supervision and provides technical guidance when required.

Risk Management

Identifies, assesses, prioritizes and manages risks without supervision and provides technical guidance when required.

Education

Bachelor's Degree or Equivalent Level

Experience

4-5 years minimum.

Company Description

TAK Automation, accredited with ISO 9001–2015, is based in Coimbatore, India and specializes in precision machined products made from ferrous and nonferrous metals, as well as aluminum. The company is led by highly qualified professionals with extensive experience in the fields of aluminum and steel foundry, CNC machining, casting, forging, welding, heat treatment, special processes, and R&D. TAK Automation is dedicated to delivering high-quality products and excelling in customer service.

Role Description

This is a full-time, on-site role for a Manufacturing Quality Engineer located in Coimbatore. The Manufacturing Quality Engineer will be responsible for ensuring quality control throughout the manufacturing process, conducting quality audits, and implementing quality management systems. The role includes tasks such as quality assurance, quality engineering, and maintaining compliance with industry standards.

Qualifications

• Experience in Quality Control and Quality Assurance
• Skills in Quality Engineering and Quality Management
• Proficiency in Quality Auditing procedures
• Strong problem-solving and analytical skills
• Excellent written and verbal communication skills
• Ability to work independently and collaboratively
• Experience in the manufacturing industry is a plus
• Bachelor's degree in Engineering or related field

Key Roles and Responsibilities

1. Quality System Development and Maintenance

The quality engineer is responsible for developing, implementing, and maintaining the Quality Management System (QMS). This includes establishing and documenting procedures, work instructions, and standards that align with industry certifications like ISO 9001 or IATF 16949. They ensure the machine shop is in compliance with all relevant regulations and customer requirements.

2. Quality Planning and Process Control

They play a central role in the planning phase of production. This includes:

• Interpreting engineering drawings and GD&T (Geometric Dimensioning and Tolerancing): Translating design specifications into actionable quality control plans.
• Developing inspection plans: Creating detailed plans for what to inspect, when to inspect it, and which tools to use at each stage (e.g., raw material, in-process, and final inspection).
• Implementing Statistical Process Control (SPC): Using statistical methods and control charts to monitor key process variables (like cutting speed and feed rate) to ensure the process remains stable and consistent.
• Conducting First Article Inspection (FAI): Performing a thorough inspection of the first part produced in a new production run to ensure it meets all specifications before mass production begins.

3. Root Cause Analysis and Corrective Actions

When a defect or non-conformance occurs, the quality engineer leads the investigation. They:

• Conduct root cause analysis: Use problem-solving methodologies (like the 5 Whys or Fishbone diagrams) to identify the underlying cause of the issue.
• Implement Corrective and Preventive Actions (CAPA): Develop and implement solutions to fix the current problem and prevent it from recurring in the future.
• Manage non-conforming materials: Ensure that defective parts are properly quarantined, dispositioned, and accounted for to prevent them from reaching the customer.

4. Inspection and Metrology

A core responsibility involves the hands-on inspection of parts. This requires a deep understanding of metrology and proficiency with various measurement tools:

• Manual tools: Using calipers, micrometers, and bore gauges for basic measurements.
• Advanced equipment: Operating and programming sophisticated machinery like a CMM (Coordinate Measuring Machine) to measure complex geometries and tight tolerances.
• Surface finish analysis: Using profilometers to ensure the surface roughness of parts meets specifications.

5. Continuous Improvement

The quality engineer is a champion of continuous improvement. They analyze quality data, identify trends, and lead initiatives to enhance product quality and process efficiency. This can involve:

• Data analysis: Using software to analyze quality metrics, such as scrap rates, first-pass yield, and customer complaints.
• Leading improvement projects: Heading projects focused on reducing defects, improving process capability, and optimizing production workflows.
• Training: Training machine operators and other staff on new quality procedures, standards, and the proper use of inspection equipment.

Industry

• Manufacturing

Company Description

TAK Automation, accredited with ISO 9001–2015, is based in Coimbatore, India and specializes in precision machined products made from ferrous and nonferrous metals, as well as aluminum. The company is led by highly qualified professionals with extensive experience in the fields of aluminum and steel foundry, CNC machining, casting, forging, welding, heat treatment, special processes, and R&D. TAK Automation is dedicated to delivering high-quality products and excelling in customer service.

Role Description

This is a full-time, on-site role for a Manufacturing Quality Engineer located in Coimbatore. The Manufacturing Quality Engineer will be responsible for ensuring quality control throughout the manufacturing process, conducting quality audits, and implementing quality management systems. The role includes tasks such as quality assurance, quality engineering, and maintaining compliance with industry standards.

Qualifications

• Experience in Quality Control and Quality Assurance
• Skills in Quality Engineering and Quality Management
• Proficiency in Quality Auditing procedures
• Strong problem-solving and analytical skills
• Excellent written and verbal communication skills
• Ability to work independently and collaboratively
• Experience in the manufacturing industry is a plus
• Bachelor's degree in Engineering or related field

Key Roles and Responsibilities

1. Quality System Development and Maintenance

The quality engineer is responsible for developing, implementing, and maintaining the Quality Management System (QMS). This includes establishing and documenting procedures, work instructions, and standards that align with industry certifications like ISO 9001 or IATF 16949. They ensure the machine shop is in compliance with all relevant regulations and customer requirements.

2. Quality Planning and Process Control

They play a central role in the planning phase of production. This includes:

• Interpreting engineering drawings and GD&T (Geometric Dimensioning and Tolerancing): Translating design specifications into actionable quality control plans.
• Developing inspection plans: Creating detailed plans for what to inspect, when to inspect it, and which tools to use at each stage (e.g., raw material, in-process, and final inspection).
• Implementing Statistical Process Control (SPC): Using statistical methods and control charts to monitor key process variables (like cutting speed and feed rate) to ensure the process remains stable and consistent.
• Conducting First Article Inspection (FAI): Performing a thorough inspection of the first part produced in a new production run to ensure it meets all specifications before mass production begins.

3. Root Cause Analysis and Corrective Actions

When a defect or non-conformance occurs, the quality engineer leads the investigation. They:

• Conduct root cause analysis: Use problem-solving methodologies (like the 5 Whys or Fishbone diagrams) to identify the underlying cause of the issue.
• Implement Corrective and Preventive Actions (CAPA): Develop and implement solutions to fix the current problem and prevent it from recurring in the future.
• Manage non-conforming materials: Ensure that defective parts are properly quarantined, dispositioned, and accounted for to prevent them from reaching the customer.

4. Inspection and Metrology

A core responsibility involves the hands-on inspection of parts. This requires a deep understanding of metrology and proficiency with various measurement tools:

• Manual tools: Using calipers, micrometers, and bore gauges for basic measurements.
• Advanced equipment: Operating and programming sophisticated machinery like a CMM (Coordinate Measuring Machine) to measure complex geometries and tight tolerances.
• Surface finish analysis: Using profilometers to ensure the surface roughness of parts meets specifications.

5. Continuous Improvement

The quality engineer is a champion of continuous improvement. They analyze quality data, identify trends, and lead initiatives to enhance product quality and process efficiency. This can involve:

• Data analysis: Using software to analyze quality metrics, such as scrap rates, first-pass yield, and customer complaints.
• Leading improvement projects: Heading projects focused on reducing defects, improving process capability, and optimizing production workflows.
• Training: Training machine operators and other staff on new quality procedures, standards, and the proper use of inspection equipment.

Industry

• Manufacturing

At first glance, you'll see that for more than 80 years we've been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and always be yourself. We're building a culture that celebrates backgrounds, experiences, and perspectives of all our associates. Look again and you'll see we are invested in you, providing the opportunity to build a meaningful career, be creative, and try new things with the support you need to be successful.
Beckman Coulter Diagnostics is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we're working at the pace of change to improve patient lives with diagnostic tools that address the world's biggest health challenges.
The Senior Manufacturing Quality Engineer for Beckman Coulter Diagnostics is responsible for:
+ Liaise with the reagent contract manufacturer and represent Beckman Coulter Quality in the interaction with the contract manufacturer and is responsible for the generation, analysis and reporting of quality metrics to relevant personnel and to ensure on-going improvement programs are put in place.
+ Lead cross functional teams providing Quality guidance and guide in the determination of appropriate NC root cause analysis and implementation of effective corrective actions.
+ Responsible for the Rework process, ensuring relevant documentation is prepared, reviewed and approved as per company procedures as well as completing Acceptable Quality Level (AQL) inspections prior to product disposition.
+ Execute the Stop Ship process for finished product released to the market, in the Oracle system, ensuring process is compliant to relevant company procedures and perform CAPA (corrective and preventive action) activities and document in the CAPA system if required.
+ Review & Approve document Change Controls (CCFs) and Equipment Change Controls (ECCs) ensuring Good Manufacturing Practices are maintained and comply with company procedures.
+ Author relevant procedures, Review/Approve documentation (e.g. protocols, reports) ensuring compliance to applicable procedures and provide Quality expertise during the product life cycle.
+ Review & Approve Certificate of Analysis(COA) for the finished goods.
This position is part of the International Quality Operations located at Ernakulam, Kerala, India and will be on-site at the OEM site. At Beckman Coulter, our mission is to Relentlessly Reimagine Healthcare, One Diagnosis at a Time.
You will be a part of the Quality, Regulatory and Clinical Affairs and report to the Senior Manager Quality and Regulatory Affairs, India Quality Operations responsible for Beckman Coulter Reagent Manufacturing Quality in India. If you thrive in a multifunctional role and want to work to build a world-class Quality organization-read on.
In this role, you will have the opportunity to:
+ Define programs for manufacturing quality improvement
+ Execute and participate in audits(supplier audits, external audits etc)
+ Liaise with Tech-ops and R&D departments on validation requirements for new and current products and processes as well as with the regional and global Q&RA organization to support the growth of and ensure alignment with BEC global policies and procedures
The essential requirements of the job include:
+ Minimum of 10 years' experience in manufacturing quality in either medical devices or pharma industry or with background in biochemistry production in a highly regulated environment with Bachelors in Biochemistry or equivalent
+ Excellent organizational and communication skills and fluent in English language is required
+ Solid working knowledge of EU, FDA and related regulations including QSR's, (FDA 21 CFR 820), ISO 13485 or ISO 9001, IVD's,
It would be a plus if you also possess previous experience in:
+ Experienced in quality management methods (8D, Six Sigma, Statistical Tools, FMEA)
+ Experienced in working within multi-functional, multi-regional teams
Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
For more information, visit .

Wondering what's within Beckman Coulter Diagnostics? Take a closer look.
At first glance, you'll see that for more than 80 years we've been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and always be yourself. We're building a culture that celebrates backgrounds, experiences, and perspectives of all our associates. Look again and you'll see we are invested in you, providing the opportunity to build a meaningful career, be creative, and try new things with the support you need to be successful.
Beckman Coulter Diagnostics is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we're working at the pace of change to improve patient lives with diagnostic tools that address the world's biggest health challenges.
The Senior Manufacturing Quality Engineer for Beckman Coulter Diagnostics is responsible for:
+ Liaise with the reagent contract manufacturer and represent Beckman Coulter Quality in the interaction with the contract manufacturer and is responsible for the generation, analysis and reporting of quality metrics to relevant personnel and to ensure on-going improvement programs are put in place.
+ Lead cross functional teams providing Quality guidance and guide in the determination of appropriate NC root cause analysis and implementation of effective corrective actions.
+ Responsible for the Rework process, ensuring relevant documentation is prepared, reviewed and approved as per company procedures as well as completing Acceptable Quality Level (AQL) inspections prior to product disposition.
+ Execute the Stop Ship process for finished product released to the market, in the Oracle system, ensuring process is compliant to relevant company procedures and perform CAPA (corrective and preventive action) activities and document in the CAPA system if required.
+ Review & Approve document Change Controls (CCFs) and Equipment Change Controls (ECCs) ensuring Good Manufacturing Practices are maintained and comply with company procedures.
+ Author relevant procedures, Review/Approve documentation (e.g. protocols, reports) ensuring compliance to applicable procedures and provide Quality expertise during the product life cycle.
+ Review & Approve Certificate of Analysis(COA) for the finished goods.
This position is part of the International Quality Operations located at Ernakulam, Kerala, India and will be on-site at the OEM site. At Beckman Coulter, our mission is to Relentlessly Reimagine Healthcare, One Diagnosis at a Time.
You will be a part of the Quality, Regulatory and Clinical Affairs and report to the Senior Manager Quality and Regulatory Affairs, India Quality Operations responsible for Beckman Coulter Reagent Manufacturing Quality in India. If you thrive in a multifunctional role and want to work to build a world-class Quality organization-read on.
In this role, you will have the opportunity to:
+ Define programs for manufacturing quality improvement
+ Execute and participate in audits(supplier audits, external audits etc)
+ Liaise with Tech-ops and R&D departments on validation requirements for new and current products and processes as well as with the regional and global Q&RA organization to support the growth of and ensure alignment with BEC global policies and procedures
The essential requirements of the job include:
+ Minimum of 10 years' experience in manufacturing quality in either medical devices or pharma industry or with background in biochemistry production in a highly regulated environment with Bachelors in Biochemistry or equivalent
+ Excellent organizational and communication skills and fluent in English language is required
+ Solid working knowledge of EU, FDA and related regulations including QSR's, (FDA 21 CFR 820), ISO 13485 or ISO 9001, IVD's,
It would be a plus if you also possess previous experience in:
+ Experienced in quality management methods (8D, Six Sigma, Statistical Tools, FMEA)
+ Experienced in working within multi-functional, multi-regional teams
Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
For more information, visit .