Hybrid Quality Assurance Associate Manager

Posted last month

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About the role

  • Manage and maintain Stryker’s Quality Management System.
  • Support internal and external audits.
  • Ensure processes meet ISO 9001 and ISO 13485 standards.
  • Coordinate quality assurance tasks, including auditing and certification processes.
  • Administer and implement the Quality Management System (CAPAs, deviations, change control, risk analysis, document control, complaints).
  • Execute internal audits and participate in external audits, following up on corrective actions.
  • Develop and implement continuous improvement programs focused on efficiency and regulatory compliance.
  • Manage and monitor warehouse processes from a quality perspective.
  • Implement local, regional, or global processes as required by the quality system.
  • Monitor key performance indicators (KPIs) and manage field action, product retention, and recall processes.

Requirements

  • Required Bachelor’s degree in Engineering or a related field.
  • 3 to 5 years of experience in quality assurance and quality management functions.
  • Experience in the medical device industry and other regulated environments.
  • Proven experience with Quality Management Systems based on ISO 9001 and ISO 13485.
  • Experience as a lead auditor.
  • Advanced English.
  • Proficiency in Microsoft Office.
  • Preferred Experience with quality management tools and ERP systems (Trackwise or similar).

Job title

Quality Assurance Associate Manager

Job type

Experience level

JuniorMid level

Salary

Not specified

Degree requirement

Bachelor's Degree

Tech skills

Location requirements

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