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    Quality Assurance Manager

    Medtronic
    5+ years
    Not Disclosed
    Gurgaon
    10 Jan. 16, 2025
    Job Description
    Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

     

    Quality Assurance Manager

    Location: Gurgaon, Haryana, India
    Time Type: Full-Time
    Posted On: 30+ Days Ago
    Job Requisition ID: R8033

    About Medtronic

    Medtronic is a global leader in healthcare technology, committed to improving lives through innovative solutions. With a team of 90,000+ passionate individuals, we strive to solve the world’s most pressing health challenges. Our mission — to alleviate pain, restore health, and extend life — is the driving force behind everything we do.

    A Day in the Life

    As the Quality Assurance Manager, you will oversee the development and maintenance of quality systems, ensuring compliance with internal and external standards. You will lead teams in monitoring quality KPIs, managing post-market issues, analyzing product complaints, and ensuring timely audits and inspections. Additionally, you will be responsible for managing non-conformities and corrective actions using tools like Trackwise, while supporting external audit preparation.

    Key Responsibilities

    • Oversee the development and maintenance of quality programs, ensuring compliance with policies and regulations.
    • Provide guidance in interpreting regulations to ensure compliance and performance standards are met.
    • Lead audits, inspections, and liaise with auditors to resolve findings.
    • Monitor and manage non-conformities and CAPA processes.
    • Support regulatory compliance through documentation, training, and quality reporting.
    • Work closely with cross-functional teams to manage quality issues, product complaints, and internal audits.
    • Manage people and talent development, ensuring operational goals are met through team performance.

    Qualifications

    Experience Required:

    • 6+ years of experience in Quality Assurance or related field, with management experience.
    • Strong knowledge of regulatory compliance in the medical device or healthcare industry.
    • Experience in managing audits, inspections, and quality documentation.
    • Proven track record in managing teams and fostering talent development.

    Knowledge & Skills:

    • In-depth understanding of quality management systems (QMS) and continuous improvement processes.
    • Strong leadership skills, with the ability to manage cross-functional teams and mentor team members.
    • Proficient in risk management, complaint management, and regulatory standards.
    • Excellent communication and problem-solving skills.

    Differentiating Factors

    • Autonomy: Leads and manages quality assurance processes with autonomy.
    • Organizational Impact: Influences operational plans, schedules, and resources to ensure the achievement of quality standards.
    • Innovation & Complexity: Tackles complex problems, proposing modifications to improve operational processes.
    • Communication & Influence: Engages with internal and external stakeholders to drive quality initiatives.
    • Leadership & Talent Management: Manages a team, guiding and developing them to meet performance objectives.

    Benefits & Compensation

    • Competitive salary and flexible benefits package.
    • Access to resources and compensation plans to support employees at all stages of their careers.

    About Us

    At Medtronic, we are committed to improving global healthcare by tackling the world’s most complex health problems. Our diverse team works collaboratively to innovate, experiment, and build solutions that improve lives. We are driven by our mission to help others, and our solutions are making a meaningful impact across the globe.

    For more information about our business, mission, and values, click here.

     

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