Senior Staff Quality Engineer

Stryker Corporation

Grecia, Costa Rica
On-site
Quality management system (qms)
Fda gmp, iso 13485, mdsap compliance
Nonconformance (ncr) and capa investigations
As a Senior Staff Quality Engineer, you will 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

  • As a Senior Staff Quality Engineer, you will 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.
  • This role is critical in maintaining product quality, minimizing risks, and supporting continuous improvement initiatives across manufacturing and engineering processes.
  • You will 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.

Matching Summary

As a Senior Staff Quality Engineer, you will 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)
  • FDA GMP, ISO 13485, MDSAP compliance
  • 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
  • Product integrity and customer trust

Key Requirements

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

Work Rights

Not specified

Tailored Resume

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