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Medical Device Quality Manager

1 month ago

Westborough, United States Talent Groups Full time
  • 5 years of experience in Quality Assurance/Quality Engineering within medical device or pharmaceutical industries.
  • Proficient understanding or demonstrated aptitude for understanding Medical Device Quality Management System (QMS) requirements and regulatory standards such as FDA CFR 21 820 and ISO 13485.
  • Familiarity with product development lifecycles, including design change and document change control.
  • Competence in process verification and validation methodologies.
  • Proficient in using word processing, spreadsheet, and presentation software.
  • Knowledgeable about continuous quality/process improvement tools.
  • Strong understanding of regulatory compliance within the medical device/pharmaceutical sectors.
  • Ability to analyze and interpret quality data to drive improvements.
  • Excellent communication and interpersonal skills.

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