Lead Quality

Year    HR, IN, India

Job Description

Why join Stryker?




Looking for a place that values your unique talents? Discover Stryker's award-winning culture.

We are proud to offer you our total rewards package which includes bonuses, healthcare, insurance benefits, retirement programs, wellness programs, as well as service and performance awards - not to mention various social and recreational activities, all of which are location specific.

Job description




We are excited to be named one of the World's Best Workplaces by Fortune Magazine!


We are proud to offer you our total rewards package which includes bonuses, healthcare, insurance benefits, retirement programs, wellness programs, as well as service and performance awards - not to mention various social and recreational activities, all of which are location specific.

What will you do



Manage Non-Conformity (NC) and Corrective and Preventive Action (CAPA) processes, support investigations across functions. Review, prepare, and update QMS documentation (procedures, work instructions, forms, policies) via Change Control processes. Execute Change Control activities in Windchill (onePLM) and manage corporate document changes through CIDT dispositions. Develop and execute the Annual Supplier Audit Plan; perform supplier audits and manage supplier-related non-conformities. Maintain Approved Supplier List (ASL) and support supplier performance reviews. Support with Management Review Meetings and coordinate Internal Quality Agreements (IQA) with divisions. Review and approve RAQA assessments for Indirect Channel (IC) partners/ distributors. Review document management for collateral materials and support validation activities as per QMS processes. Conduct internal audits per the audit program and coordinate Quality Review Board (QRB) meetings. Support warehouse quality team with label Master updates and product inspections. Manage electronic QMS systems such as Track Wise, training systems, and documentation platforms. Plan and coordinate training activities with functional heads to enhance the QMS; maintain and update the annual Training Plan. Perform additional duties as assigned by the Manager.

Technical Expertise



Strong understanding of ISO 13485, Good Distribution Practices (GDP), and regulatory requirements for medical devices. Knowledge of quality improvement methodologies and compliance frameworks.

What you need

Experience: minimum 6 and maximum 8 years in Quality function within Medical Device or Pharmaceutical industry. Education: Master's degree in biomedical engineering, Biotech Engineering, Life Sciences, or Pharmacy. Certifications: ISO 13485:2016 Lead Auditor certification. Proven experience in QMS development, implementation, and maintenance aligned with local regulations. Expertise in audits (supplier, internal, corporate) and compliance risk management. Ability to work independently with a strong sense of urgency and follow-up. Willingness to travel up to 20% (warehouses and suppliers/distributors).
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually.

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Job Detail

  • Job Id
    JD5127177
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    HR, IN, India
  • Education
    Not mentioned
  • Experience
    Year