Senior Staff Quality Engineer

Stryker

Onsite
Quality management system (qms)
Nonconformance (ncr) and capa investigations
Risk management tools (fmea)
Play a key role in ensuring the effectiveness of the Quality Management System (QMS) and compliance with applicable regulatory standards such as FDA GMP, ISO 13485, and MDSAP

Job Summary

  • Play a key role in ensuring the effectiveness of the Quality Management System (QMS) and compliance with applicable regulatory standards such as FDA GMP, ISO 13485, and MDSAP.
  • Collaborate cross-functionally to resolve quality issues, enhance processes, and ensure compliance with both internal and external requirements, ultimately safeguarding product integrity and customer trust.
  • Support internal, external, and supplier audits; address audit findings and review engineering changes to ensure product quality and compliance.

Matching Summary

Play a key role in ensuring the effectiveness of the Quality Management System (QMS) and compliance with applicable regulatory standards such as FDA GMP, ISO 13485, and MDSAP.

Skills & Requirements

Must-have

  • Quality Management System (QMS)
  • Nonconformance (NCR) and CAPA investigations
  • Risk Management tools (FMEA)
  • validation activities (IQ, OQ, PQ)
  • electronic Quality Management Systems (eQMS)

Nice-to-have

  • continuous improvement initiatives
  • cross-functional collaboration
  • customer trust

Key Requirements

  • Bachelor’s degree in Engineering
  • Minimum 7 years of experience
  • Experience in software validation
  • Strong knowledge of advanced statistics
  • Working knowledge of 21 CFR Part 820
  • Working knowledge of ISO 13485
  • Advanced English

Work Rights

Not specified

Tailored Resume

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