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    Senior Quality Assurance - Bengaluru, India - Indegene

    Indegene
    Indegene Bengaluru, India

    Found in: Talent IN 2A C2 - 1 day ago

    Default job background
    Pharmaceutical / Bio-tech
    Description

    We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations to be future ready. We offer accelerated, global growth opportunities for talent that's bold, industrious and nimble. With Indegene, you gain a unique career experience that celebrates entrepreneurship, and is guided by passion, innovation, collaboration and empathy. To explore exciting opportunities at the convergence of healthcare and technology, check out

    What if we told you that you can move to an exciting role in an entrepreneurial organization without the usual risks associated with it?

    We understand that you are looking for growth in your career at this point and we would love for you to join us in our journey and grow with us. At Indegene, our roles come with the excitement you require at this stage of your career with the reliability you seek. We believe in creating leaders of tomorrow and mentor our leads to help them grow and nurture them as people managers and account managers.

    We are a rapidly growing global organization and are scouting for the best talent for this phase of growth. With us, you are at the intersection of two of the most exciting industries of healthcare and technology. We offer global opportunities with fast-track careers while you work with a team that is fueled by purpose. The combination of this will lead to a truly differentiated experience for you.

    If this excites you, then apply below.

    Senior Quality Assurance Associate

    You will be responsible for:

    Summary:

    The Senior Quality Assurance Associate plays a vital role in ensuring the quality and safety of medical devices throughout the product lifecycle. This individual will be responsible for a wide range of tasks, including developing and maintaining quality documentation, conducting audits and inspections, and supporting risk management activities. The ideal candidate will have a strong understanding of medical device regulations and quality standards, along with experience in the medical device industry.

    Roles and Responsibilities:

    • Develop, implement, and maintain quality system documentation (SOPs, WIs, templates, forms) adhering to QMS requirements and regulations (ISO 13485, 21 CFR 820).
    • Conduct a thorough gap analysis, meticulously comparing product standards against current QMS requirements. Identify discrepancies and develop a roadmap for implementing necessary process engineering changes.
    • Conduct internal audits and inspections to assess quality procedure compliance and identify improvement opportunities.
    • Participate in external audits by regulatory and notified bodies.
    • Support risk management activities (plan development, risk assessments, mitigation strategies).
    • Investigate and analyze non-conformance reports, complaints, and CAPA events (root cause identification, corrective actions).
    • Oversee data collection and analysis for Quality KPIs, preparing reports to monitor quality trends.
    • Liaise with engineering, manufacturing, and regulatory affairs to ensure quality integration throughout the product lifecycle.
    • Provide technical support to the QA team and participate in cross-functional teams.
    • Ability to create training materials based on QMS and provide the training to the cross-functional teams.
    • Maintain up-to-date knowledge on medical device regulations (ISO 13485:2016, 21 CFR 820, ISO and update quality documentation accordingly.
    • Participate in training programs to enhance quality knowledge and skills.
    • Assist with developing and implementing quality training programs for other staff members.
    • Excellent organizational, verbal, written communication and time management skills that are action oriented and customer focused.
    • (Optional) Participate in the design review process, ensuring quality is integrated into medical device design.
    • (Optional) Support the validation and verification of medical devices.
    • (Optional) Assist with developing and implementing quality control procedures.
    • (Optional) Manage and maintain quality records.
    • (Optional) Travel to manufacturing sites or customer locations as required.

    Your impact:

    About you:

    • Excellent communication, interpersonal, and collaboration skills.
    • Proficient in Microsoft Office Suite.
    • Strong attention to detail and commitment to quality.
    • Excellent problem-solving and analytical skills.
    • Ability to work independently and as part of a team.
    • Ability to prioritize tasks and meet deadlines.
    • (Optional) Experience with design control principles.
    • (Optional) Experience with validation and verification methodologies.
    • (Optional) Working knowledge of quality control techniques.

    Must have:

    Qualifications:

    • Bachelor's degree in Science or Engineering (preferred) or a related field.
    • Minimum of 3 years of experience in medical device quality assurance or a related field.
    • Strong understanding of ISO 13485:2016 and relevant quality requirements (e.g., 21 CFR 820, MDSAP).
    • Strong understanding of medical device regulations (e.g., EU MDR 2017/745, US FDA, etc.,)
    • Experience with developing and maintaining quality system documentation.
    • Experience with conducting audits and inspections.
    • Proven ability to analyze data and identify trends

    EQUAL OPPORTUNITY

    Indegene is proud to be an Equal Employment Employer and is committed to the culture of Inclusion and Diversity. We do not discriminate on the basis of race, religion, sex, colour, age, national origin, pregnancy, sexual orientation, physical ability, or any other characteristics. All employment decisions, from hiring to separation, will be based on business requirements, candidate's merit and qualification.

    We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, gender identity, sexual orientation, disability status, protected veteran status, or any other characteristics.

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