1,286 Quality Systems jobs in India
Business & Technical Analyst - Quality Management Systems
Posted today
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Job Description
Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at .
**Astellas' Global Capability Centers - Overview**
Astellas' Global Capability Centers (GCCs) are strategically located sites that give Astellas the ability to access talent across various functions in the value chain and to co-locate core capabilities that are currently dispersed. Our three GCCs are in India, Poland and Mexico.
The GCCs will enhance our operational efficiency, resilience and innovation potential, enabling a timely response to changing business demands. Our GCCs are an integral part of Astellas, guided by our shared values and behaviors, and are critical enablers of the company's strategic priorities, sustainable growth, and commitment to turn innovative science into VALUE for patients.
This position is based in Bengaluru and will require some on-site work.
**Purpose and Scope:**
As individual contributor of a team of individuals in a specific area of digital expertise, you will be a crucial player in driving our digital initiatives forward in our agile organization. Our agile operating model consists of two components - **Digital Capability** and **Digital Execution** . Digital Execution are about aligning multiple missions around business goals and facilitating collaboration on a larger scale. Digital Capability, on the other hand, focus on the growth and development of individuals within a specific expertise area. This **dual structure** enables us to **scale agile practices** efficiently while maintaining a focus on both product development and individual skill enhancement.
A Business & Technical Analyst is a multifaceted role that bridges the gap between business needs and technical solutions. This position involves analyzing and translating business requirements into technical specifications, ensuring that the solutions developed meet the business goals and user needs. The role requires a blend of business acumen, understanding of technical architectures, and the ability to communicate effectively with both business stakeholders and technical teams.
You will be at the forefront of implementing innovative solutions and will have the opportunity to work on cutting-edge technologies in your field.
**Essential Job Responsibilities:**
+ **Business Requirements Analysis:** Collaborate with business stakeholders to understand their needs, goals, and objectives. Analyze business processes and workflows to identify improvement opportunities and define requirements for solutions.
+ **Technical Specification Development:** Translate business requirements into detailed technical specifications that guide the development of software applications, systems, or processes. Ensure that these specifications meet both the business needs and technical standards.
+ **Solution Design and Recommendation:** Work with Digital and software development teams to design solutions that fulfill business requirements. Evaluate potential technical solutions for feasibility, cost-effectiveness, and alignment with business objectives.
+ **Stakeholder Collaboration:** Serve as a liaison between business units and technical teams to ensure clear communication and understanding of project goals, requirements, and constraints. Facilitate meetings and discussions to gather feedback and consensus.
+ **Project Management Support:** Assist in project management tasks, such as planning, scheduling, and tracking progress. Ensure that projects stay on track to meet deadlines and budget constraints.
+ **Testing and Quality Assurance:** Participate in the testing of developed solutions to ensure they meet the defined requirements and standards. Assist in identifying and documenting bugs or issues for resolution.
+ **Training and Support:** Develop training materials and provide support to users on new systems or applications. Ensure that end-users are equipped to use the new solutions effectively.
+ **Documentation:** Create and maintain documentation related to business requirements, technical specifications, project plans, and reports to ensure knowledge is captured and shared.
**Qualifications:**
**Required**
+ Bachelor's degree in relevant field, e.g., Computer Science, Data Science, Business Administration.
+ Demonstrated experience in business analysis, technical analysis, or a related area, demonstrating a track record of bridging business needs with technical solutions.
+ Experience with Salesforce, TrackWise Digital and Veeva platform solutions
+ Analytical Skills: Strong analytical and problem-solving skills to understand complex business issues and develop appropriate technical solutions.
+ Technical Knowledge: Good understanding of information technology, software development life cycles, and architectural frameworks. Familiarity with programming languages, databases, and software development tools is beneficial.
+ Communication Skills: Excellent verbal and written communication skills, with the ability to convey technical concepts to non-technical stakeholders and vice versa.
+ Collaboration: Ability to work effectively in a team environment, collaborating with diverse groups of stakeholders, including business users, Digital professionals, and management.
+ Project Management: Good knowledge of Agile methodology, principles and practices.
+ Attention to Detail: Precision in documenting requirements, specifications, and project details to ensure clarity and alignment with objectives.
+ Adaptability: Flexibility to adapt to changing requirements, technologies, and project priorities.
+ Experience with system integration and data migration
+ Good Knowledge of ERP, Quality, Regulatory, Clinical systems and operations
**Preferred**
+ Life Sciences / Pharma industry experience
+ Certifications in specific technologies, architecture frameworks (e.g., TOGAF), Agile delivery methodologies (e.g., SAFe) can be beneficial.
+ Agile Champion: Adherence to DevOps principles and a proven track record with CI/CD pipelines for continuous delivery
**Working Environment**
This position is based in Bengaluru and will require some on-site work.
Category PlatformX
Astellas is committed to equality of opportunity in all aspects of employment.
EOE including Disability/Protected Veterans
Quality Management Officer
Posted 23 days ago
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Interface with external parties, including vendors and regulatory bodies, to manage quality expectations.
Provide detailed reports and recommendations to senior management regarding quality improvement initiatives.
Company Overview
Sri Sai Overseas Recruitment is a leading Manpower Recruitment & Consultancy Service provider founded in 2019. Headquartered in Vadodara, the company specializes in delivering exceptional recruitment services in India, the Middle East, Europe, and beyond. With expertise gained from professionals experienced in the Gulf countries' Oil & Gas sectors, Sri Sai Overseas Recruitment is committed to understanding and fulfilling client needs across diverse industries globally. For more details, visit our website at Sri Sai Overseas Recruitment .
Job Overview
We are seeking a qualified Junior-level Quality Management Officer to join our team at our Vadodara headquarters. This full-time role involves ensuring compliance across various projects and maintaining high-quality standards. The position is ideal for professionals keen to ensure quality assurance practices and operations. With a dedicated team, Sri Sai Overseas Recruitment is committed to aligning with client needs and ensuring successful global placements.
Qualifications and Skills
- Proficiency in performing root cause analysis to identify problems and recommend effective solutions.
- Experience with statistical process control to monitor and control quality assurance processes.
- Familiarity with total quality management principles aimed at enhancing quality standards and performance.
- Capability to conduct quality audits and ensure processes comply with regulations.
- Understanding of microbiology principles relevant to quality control and assurance.
- Ability to develop and maintain standard operating procedures to enhance operational efficiency.
- Experience in total quality management for consistency and quality in processes.
- Proficiency in FDA regulations (Mandatory skill for ensuring product safety and compliance).
Roles and Responsibilities
- Indent and receipt media, chemicals, reagents for microbiology lab and maintain receipt records.
- Maintain daily usage logbooks of Balance, water bath, PH Meter, Laminar Airflow, Incubator, Fogger, and Antibiotic zone reader & colony counter.
- Maintain daily monitoring records of Refrigerators temperature, incubator temperature, relative humidity (RH), temperature & differential pressure.
- Keep calibration records of PH Meter and analytical balance, as well as all instruments in the Microbiology department.
- Maintain disinfectant preparation & microbiology area and instruments cleaning records.
- Maintain environment monitoring records of settle plate & air sampler methods.
- Prepare MLT reports of raw materials, bulk & finished products.
- Indent media and chemicals required in the microbiology lab.
- Carry out Growth promotion tests (GPT) as per SOP.
- Document daily media preparation & its record as per SOP.
- Maintain autoclave sterilization record of slow exhaust cycle & HPHV cycle.
- Conduct water sampling, analysis & record as per SOP.
- Perform microbial limit test (MLT) of stability products, bulk, raw material & its record as per SOP.
- Conduct bioassay of B12 for bulk.
- Document culture dilution & its records.
- Maintain subculturing and its records.
- Perform swab, rinse, and drains analysis.
Senior Manager, Quality Control Systems Templating
Posted 2 days ago
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Job Description
**Role Name:** QC Systems Templating Senior Manager
**Department Name:** Quality Control
**Role GCF:** 6
**ABOUT AMGEN**
Amgen harnesses the best of biology and technology to fight the world's toughest diseases, and make people's lives easier, fuller and longer. We discover, develop, manufacture and deliver innovative medicines to help millions of patients. Amgen helped establish the biotechnology industry more than 40 years ago and remains on the cutting-edge of innovation, using technology and human genetic data to push beyond what's known today.
**ABOUT THE ROLE**
**Role Description:**
Let's change the world. In this vital role you will lead the team responsible for creation and management of master data templates for QC systems, including ELN (electronic laboratory notebook) and the consumable inventory system, used globally across the Amgen QC network. You will use strategic planning and prioritization to support the collective requirements of the QC organization alongside the individual needs and timelines of the sites.
This candidate will primarily work during regular working hours (9 am - 6 PM local time) to enable the business in delivering Amgen's mission to serve patients and will lead a shift-based team that provides coverage in support of the Amgen network across multiple time zones. The candidate may need to work outside of his/her routine workday to support business needs and will be responsible for determining the same for their staff. The individual will be required to work from our office located in Hyderabad India (Amgen India-AIN).
The candidate will also lead the remote support from AIN to Amgen sites across multiple time zones globally.
As Senior Manager in the Quality Control organization, you're in a leadership position with responsibilities to supervise and mentor staff. As a leader, you will focus your efforts on the following functions in support of global QC systems operations:
**Roles & Responsibilities:**
+ Oversight of the AIN-based QC Systems team in support of QC system master data creation, management and qualification
+ Collaboration with the global business process owner(s) to resolve issues encountered by the team
+ Management of request prioritization in alignment with QC network needs
+ Maintaining alignment between sites on use of QC systems and driving further standardization of testing documentation
+ Collaboration with other global and site-based QC teams to achieve QC network goals
+ Supportstafftraining,careerdevelopmentandperformancemanagement of team across all three shifts
+ Responsibleforensuringcompliancewithsafetyguidelines,cGMPsandotherapplicable regulatory requirements
+ Champion process improvements to increase efficiency and productivity
+ Assign workload appropriately and strategically based on required interactions with sites in the QC network across multiple timezones
The following are some examples of tasks for the position
+ Evaluate master data requests and categorize based on complexity
+ Assign requests taking into consideration priority, network alignment and requested completion timelines
+ Track progress of requests in alignment with due dates, and course correct as necessary
+ Escalate roadblocks faced by the team to avoid impact to achieving targets
+ Applyanalyticalskillstoevaluateandinterpretcomplexsituations/problemsusingmultiple sources of information
+ Anticipateandpreventpotentialproblems with engagement in the network of knowledge sharing in near misses
+ Provide updates to the global QC networkonmetrics,analyzingdataand recommending improvements
**Basic Qualifications and Experience:**
Master's degree with 12-16 years of Pharma and Biotech commercial or clinical manufacturing Quality Control experience.
In addition to meeting the above requirement, you must have a minimum of 5-7 years experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources. Your managerial experience may run concurrently with the required technical experience referenced above.
**Functional Skills:**
+ Strongprojectmanagementskillsandexperiencesupervisingprofessionals in a Quality organization working with cross functional and global stakeholders across multiple time zones
+ WorkingknowledgeofcGMPregulations,practices,andtrendspertainingtoQuality Control
+ Experiencewithvariouslaboratorycomputersystems, equipment/instrumentation, andapplications
**Soft Skills:**
+ Excellent written and verbal communication skills, ability to work in a team environment and build relationships with partners
+ Track record of building and maintaining a high performing team
+ Strong leadership and negotiation skills with a demonstrated ability to influence others
+ Demonstrated innovative thinking and ability to transform work organizations
+ Demonstrated ability to navigate through ambiguity and provide structured problem solving
+ Demonstrated ability to deliver right the first time on schedule in accordance with established Service Level Agreements
+ Demonstrated skills in staff motivation, coaching/mentoring and professional development
**EQUAL OPPORTUNITY STATEMENT**
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided with reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
Assistant Manager-Quality Management
Posted 5 days ago
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Role- Assist-Manager Quality
Experience-8+Years
Location-Hyderabad
Mandatory skills- Quality, Quality consulting, CMMI 3.0, Agile,
Metric and analysis, Agile Methodology & CMMI Practices.
Project Lifecycle Support Initiation, Execution, Closure.
LEAN, Six Sigma, Zero Distance Initiatives.
Vulnerability Management Tools Scan Execution & Reporting.
SOC Audit Handling & ASAM Ticket Management.
Roles and Responsibilitiy,
1. Introduction
This JD provides an overview of the Software Quality Advisors role and responsibilities.
1.1 Scope of Software Quality Advisor (SQA) Role
The basic objectives of the Software Quality Advisors role are to:
- Assist project to implement Quality Management System (QMS)
- Provide relevant process related training.
- Ensure compliance to projects planned processes.
- Assist in metrics and milestone analysis.
- Perform a closure analysis at project closure.
Skill Set
- CMMI Integrated V2.0 framework.
- ISO Integrated 9001:2015 and ISO 20K standards.
- Quantitative Project Management Building prediction models & Alternative models.
- Agile Methodology/ CMMI Implementation
- Value stream mapping workshop, Demand Capacity & Reduction analysis, Meeting time analysis, Documentation analysis, DILO & Context switching analysis, Management time analysis, Team structure analysis, Span of control analysis, Skill heat-map analysis, Individual variability analysis & Onsite team optimization etc.
- Improve delivery practices leading to significant and sustainable Productivity Improvement in FP projects.
- Contract renewal, T&M to FP conversion, new business wins, meet committed productivity numbers in non-FP projects.
- Improve estimation practices for new bids.
- Worked on Excel, Power BI Report builder, R Studio & Process model (SVC)
2. Software Quality Advisor Activities
SQAs activities can be split across two main streams:
- Process Consultation
- Continuous Improvement
2.1 Process Consultation to the project team during the following phases of a project
- Project Initiation
- Project Execution
- Project Closure Activities
2.1.1 Project Initiation Activities:
During the project initiation phase, the activities that are SQA would assist the project manager and project team would include,
- Understand the scope of the project, client quality requirements along with contractual commitments.
- Understand the interdependencies between various teams which are involved in meeting the clients' requirements.
- Organize a Project Kick Off meeting with all the relevant stakeholders. (Refer Project kick-off ppt template in the Quality Teams SharePoint site under Project Management (PM) Templates for the required details for this meeting)
- Assist the Project manager in tailoring the appropriate processes and guidelines for the execution of the project.
- Set up the project goals for the project based on the objectives of the project.
- Assist the Project Manager in orientation on the Quality system and customizing of the same.
- Ensure that the scientific techniques for Estimation (Function Point (FP), SMC, etc.) and Scheduling are used.
- Assist in identification of Risks in the project and setting up of mitigation plan of the risk.
- Identify the need for process training amongst the project team members and plan for organizing the same Prepare the SQA plan for the project with details of strategies, project review and enabling plan.
- Assist Project Manager in identifying and deploying Organization Level Initiatives in the Project like Zero Distance, LEAN, Six Sigma, etc.
- Participate in group review of Project management plan and Configuration management plan.
2.1.2 Project Execution Activities:
Following are the primary activities that are performed by the SQA, during project execution.
- Conduct frequent health checks of the project. Partner the projects in understanding the Top issues and consult them in mitigating it.
- Monitor the progress of the project using Project Performance Snapshot (PPS).
- Verify Project’s Compliance to the processes defined in the project management plan as per the Review plan defined in the SQA plan.
- Provide a detailed report (PPS) to all the stakeholders on the compliance status of the project.
- Assist during Internal audit for the project which is scheduled. Track the closure of Non-conformances raised in the audit.
- Assist the Project Manager in analyzing the customer feedback for the project on a periodic basis
- Participate in Causal Analysis & Resolution (CAR) meetings, Defect Prevention (DP) meetings for the project as required.
- Perform Periodic analysis of the project’s data and present to the Stakeholders (Project Team, Delivery Manager (DM) and Senior Leadership).
- Drive the implementation of Organization Level / Project Level initiatives to achieve goals.
- Assist Project Managers to participate in various Reward & Recognition programs.
2.1.3 Project Closure Activities:
During the closure phase of the project, the SQA will
- Assist the Project Manager in preparing the final PPS report for the project within the provided timelines.
- Analyse the Quality and Productivity parameters for any deviations.
- Capture the lessons learned from the project execution for future reference.
- Assist the Project Manager in closing the project in all relevant systems.
A detailed checklist of activities for the SQA is given in this document for reference. Deliverables of the SQA are also described in this document.
2.2 Partnering the DU/Unit/Organization in continuous improvement: The list of activities would include.
- Provide periodic reports to the Delivery management on the hygiene status, process performance status along with details of initiative rollout status
- Proactively identify areas of risk and assist the delivery teams in mitigating the risks.
- Identifying the opportunities for improvement and Rollout of Change Initiatives across the DU/Unit/Account/Organization
- Conduct structured analysis on the past process performance of the DU/Unit/Account/Organization on a periodic basis.
- Identify the areas of focus and opportunities for improvement in the coming period.
- Partner with delivery teams in identifying strategies for actionizing on the improvement opportunities
- Ensure deployment of strategies identified across the projects
- Monitor the status of deployment and results.
- Provide strategic support in driving delivering excellence and client satisfaction
3. Deliverables
Below are the deliverables that are expected of a SQA
- SQA Plan
- Compliance reports and the Non-Conformance closure report if any.
- Data analysis reports (if any)
- Closure reports (PPS)
- Any other reports that the SQA has prepared for the project.
- Training records
- Lessons Learned or Process Improvement suggestions.
In case of change in the SQA, previous activities & artifacts including project related mails shall be handed over to the new SQA.
4. SQA Reports to Management
SQA must send the Project Performance Report with a minimum frequency of once per week to the DM and Quality Manager, or as agreed between them.
The structure of the report can be decided based on the requirements of the stakeholders. Some of the details that the report could contain includes,
- Activities Performed during the period ex: Compliance check, Internal Audits, Reviews etc. and pending actions or NCRs.
- Risk Status
- CMMi status
- Hygiene
- Casual Analysis and Resolution
- Metrics
- CM audit
- Organization / Unit level Improvement Initiatives Status
- Quality and Productivity values and analysis for the deviation.
- Issues needing DM's attention.
5. Handling vulnerability management
- Hands on experience on any vulnerability management tool.
- Able to run the scans/reports on any tool.
- Expertise in addressing tool issue.
- To Handle access related and license renewal related issues.
- Trouble shoot on any tool issues and guiding team in fixing them.
- Able to coordinate with external stake holders/vendors.
- Coordinating with project teams on scan template reviews.
- Identify the severity of vulnerability/issue and guide project teams in addressing the fixes.
- Handling code moves, ASAM tickets and SOC audits.
Regards,
Infosys BPM Recruitment team
Sap Quality Management Consultant
Posted 5 days ago
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Role Summary:
We are seeking a seasoned Senior SAP QM Consultant to lead and deliver end-to-end SAP Quality Management implementation. The ideal candidate will possess a strong understanding of procured material inspection processes—including quality planning, inspection execution, continuous improvement, root cause analysis, and analytics—and demonstrate deep expertise in SAP QM functionalities. This includes seamless integration with other SAP modules and hands-on experience across the full project lifecycle: blueprinting, configuration, testing, training, and go-live support.
Key Responsibilities:
- Lead SAP QM module implementation across multiple phases: requirement gathering, design, configuration, testing, deployment, and post-go-live support.
- Collaborate with business stakeholders to understand quality processes and translate them into SAP solutions.
- Configure SAP QM functionalities including inspection planning, results recording, quality notifications, and audit management.
- Integrate QM with SAP PP, MM, SD, and other relevant modules.
- Prepare functional specifications for custom developments and coordinate with ABAP developers.
- Conduct workshops, training sessions, and UAT with business users.
- Manage project timelines, deliverables, and stakeholder communication.
- Provide expert-level troubleshooting and support during hypercare.
- Ensure compliance with industry standards and internal quality policies.
Required Qualifications:
- Bachelor’s or Master’s degree in Engineering, IT, or related field.
- 10+ years of SAP QM experience with at least 3 full-cycle implementations.
- Strong understanding of manufacturing and quality processes.
- Experience with SAP ECC and/or S/4HANA environments.
- Proficiency in integration with SAP PP, MM, SD.
- Excellent communication, leadership, and stakeholder management skills.
- Ability to work independently and lead cross-functional teams.
Preferred Skills:
- SAP QM certification.
- Familiarity with tools like LSMW, interfaces and Fiori apps.
- Six Sigma methodology
- Knowledge of Agile or hybrid project methodologies.
- Build Control Charts based on specifications like CTQ etc, alerting mechanism and follow-up actions by suppliers or parts . Capture summary of observations and actions in a Dashboard
- Applying AI/ML to predict quality of supplier parts
- Experience in Semiconductor or repetitive manufacturing Industry.
Quality Management-Sr. Executive
Posted 23 days ago
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Company Overview
Dr. Moopens Medical College is a leading institution in the Hospital & Health Care industry, based in Kerala. With a workforce of over 1000 employees, the college is committed to delivering high standards in medical education and healthcare services. Located in Wayanad, its mission is to foster excellence through continual improvement, ensuring the well-being of patients and quality medical education.
Job Overview
We are seeking a highly experienced Quality Management Senior Executive to join our team at Dr. Moopens Medical College, located in Wayanad. This is a full-time position with a focus on enhancing quality processes within our institution. The ideal candidate will have a deep understanding of quality management principles and a track record of implementing effective quality control measures in a healthcare setting.
Qualifications
- Master Degree in Hospital Management, PGDHM, or B.Sc Nursing.
- Proficiency in Six Sigma and Total Quality Management is mandatory for streamlining processes and improving efficiency.
- A strong understanding of ISO 9001 and its application in maintaining high standards of healthcare services.
- Experience in Lean Management to foster a culture of continuous improvement and waste reduction.
- Expertise in Root Cause Analysis to effectively identify and address underlying issues affecting quality.
- Capability to execute Quality Assurance Testing to ensure compliance with established standards and regulations.
- Knowledge of Statistical Process Control to monitor and control processes, ensuring high-quality outputs.
- Competence in Risk Management to anticipate and effectively mitigate risks impacting quality.
- Preferred experience of NABH 6th Edition Standards.
Roles and Responsibilities
- Lead, develop, and implement quality management initiatives consistent with hospital policies and regulatory standards.
- Conduct thorough audits and reviews to assess the effectiveness of existing quality systems and procedures.
- Collaborate with cross-departmental teams to promote quality awareness and drive continuous process improvement.
- Utilize Six Sigma strategies to improve healthcare delivery and drive patient satisfaction.
- Develop and conduct training sessions to enhance competencies in quality management among staff.
- Analyze quality data to identify areas of improvement and develop actionable plans for enhancement.
- Engage in strategic planning to incorporate quality management in the institution's overall strategic vision.
TrackWise Quality Management System (QMS)
Posted 1 day ago
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Role: TrackWise Expert
We are seeking an experienced TrackWise Expert to lead the end-to-end design and implementation of scalable, compliant, and high-performance enterprise quality management system. The ideal candidate will bring strong expertise in solution architecture, design and system integration
Work Type: Remote
Location: Offshore (India)
Start date: Immediate
Duration: 6 months plus
Key Responsibilities:
- Lead end-to-end solution architecture for TrackWise Digital implementations.
- Translate business requirements into scalable, maintainable, and compliant technical solutions.
- Define and implement architecture standards, patterns, and frameworks for digital quality systems.
- Provide technical guidance and mentorship to development and integration teams.
- Establish and enforce coding standards, design principles, and development best practices.
- Ensure reliable data flow, synchronization, and API management across platforms.
- Collaborate with middleware and enterprise integration teams to ensure seamless connectivity.
- Support system validation, documentation, and audit readiness for quality systems.
- Partner with business analysts, product owners, and QA teams to align solutions with business goals.
- Clearly communicate architectural decisions, trade-offs, and recommendations to both technical and non-technical stakeholders.
- Excellent communication and leadership skills.
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Automated Systems Quality Assurance Engineer (Remote)
Posted 1 day ago
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Quality Assurance Engineer - Automotive Systems
Posted 20 days ago
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ISO 9001-Quality Management Consultant/Management Representative
Posted 1 day ago
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Smartedge Consulting is a leading multi-disciplinary ISO consulting company based in Hyderabad. We specialize in providing management systems consulting services for various certifications, including ISO 9001, ISO 14001, OHSAS 18001, and ISO 27001. Our approach includes conducting initial gap analyses, project planning, requirements identification, training, and documentation to ensure our clients meet their specific certification goals.
Job Title
ISO 9001-QMS Consultant/ Management Representative
Location
Project-based / Client Sites / Full time onsite
Role Objective
To deliver consulting, documentation, training, and internal auditing services for the implementation and maintenance of ISO 9001 management systems for clients across various industries.
Key Responsibilities
Project Delivery
- Lead gap assessments, process mapping, documentation development, and implementation support for ISO 9001.
- Facilitate client-specific process improvements, risk assessments, and legal compliance evaluations.
- Conduct internal audits as per ISO 19011 guidelines.
- Support clients in management review meetings and certification body audits.
Client Engagement
- Understand client-specific industry requirements (Manufacturing, Pharma, Services, Infra, etc.).
- Maintain effective communication with client teams to manage expectations and build trust.
- Provide value-added insights beyond compliance requirements.
Training & Competency Building
- Deliver awareness, implementation, and internal auditor training programs.
- Develop customized training materials.
Documentation & Reporting
- Prepare and review manuals, procedures, SOPs, and forms as per ISO standards.
- Prepare audit reports, project status updates, and client feedback summaries.
Continual Improvement
- Identify opportunities for improving internal consulting methodologies and client outcomes.
- Stay updated with industry practices, ISO updates, and statutory regulations.
Technical Competencies
· ISO 9001:2015 implementation & audit expertise
· Effective client communication
· ISO 19011:2018 Internal Auditing Techniques
· Problem-solving and decision-making
· Knowledge of legal and other applicable industry requirements
· Team collaboration and knowledge sharing
· Documentation development (Manuals, Procedures, SOPs)
· Professional ethics and confidentiality
· Process improvement tools (Root Cause Analysis, PDCA, etc.)
· Adaptability and learning agility
Key Result Areas (KRAs) & KPIs
· Measurement Criteria (KPI)
· Timely Project Delivery
· % of projects delivered on schedule
· Client Satisfaction
· Client feedback score / Retention rate
· Documentation Quality
· Number of reworks / NCs in certification audit
· Training Effectiveness
· Training hours delivered / Participant feedback
· Internal Audit Delivery
· Number of audits conducted / Audit report quality
· Compliance & Legal Awareness
· Number of legal registers / updates provided
Preferred Qualifications & Experience
- Bachelor’s in Engineering any branch/BSc/BBA
- Certified Lead Auditor / Internal Auditor for ISO 9001.
- 3–5 years of trouble shooting experience in management system consulting, audits
- Exposure to multiple industry sectors preferred.
Employment Type
Full-Time
Remuneration
This is junior level position only longer experience is not recommended