Senior Quality Assurance Specialist

1 month ago


Gurgaon, Haryana, India Stryker Global Technology Center Pvt Ltd. Full time

Stryker Global Technology Center Pvt Ltd is a leading manufacturer of medical technology, and we are seeking a highly skilled Senior Quality Assurance Specialist to join our team.

About the Role

We are looking for a talented individual with expertise in quality management, risk assessment, and regulatory compliance to drive our product development process forward.

The successful candidate will have a strong understanding of ISO 13485, 21 CFR 820, and other relevant industry standards. They will be responsible for leading internal audits, participating in corporate and FDA audits, and ensuring that all procedures are compliant with GMP regulations.

In addition to their technical skills, the ideal candidate will possess excellent communication and collaboration skills, able to work effectively with cross-functional teams and provide guidance on quality-related matters.

Key Responsibilities
  • Lead product quality-related projects, including risk assessments, supplier selection, and validation.
  • Develop and maintain quality procedures, ensure adherence to GMP regulations, and author/review documents as required.
  • Collaborate with operations teams to develop and maintain a robust internal and external supply chain.
  • Support process validation programs, conduct internal audits, and participate in corporate and FDA audits.
  • Provide inputs for NPDPs and ensure adherence to QMS and Good Documentation practices.
Requirements
  • Bachelor's degree in mechanical/biomedical/biotech engineering or related field.
  • Minimum 3-5 years of relevant work experience in quality assurance, risk management, or a related field.
  • Expert-level knowledge of current industry standards for new product development and risk management practices.
  • Demonstrated ability to effectively work with others in various coordinate disciplines and on multi-national teams.
Estimated Salary Range: $120,000 - $180,000 per year

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