ISO13485 QA Lead - Hybrid (Medical Devices)

Perrigo Company; Oost-Vlaanderen; Hybrid; EUR 60,000 - 90,000; Full time

Benefits offered by this job

Hybrid working (2 days from home)

Total Rewards program

Job summary

Perrigo Company is seeking a Quality Assurance Associate to manage QA activities for Perrigo Medical Devices products, including CMOs, and to support the Quality Management System across development, validation, and regulatory compliance. The role emphasizes collaboration with cross-functional teams in a fast-paced, global environment.

The ideal candidate has 8–10 years in life-science and medical devices, with 5+ years in QA, and strong knowledge of ISO13485 and MDR.

Qualifications

• 8–10 years of experience in life-science industry and Medical Devices management.
• Ideally, >5 years in quality assurance.

Responsibilities

• QA activities for Perrigo Medical Devices products, including CMOs under responsibility.
• Prepare, review and approve protocols/reports provided by the CMO.
• Support maintenance of the Quality Management System (SOPs and templates).
• Coordinate with stakeholders to ensure Perrigo products stay compliant with regulations and standards.
• Open and manage non-conformities, deviations, change controls, CAPA and other QA processes.
• Perform audits of manufacturers under ISO13485 and MDR scopes.

Skills

ISO13485 knowledge

MDR knowledge

Medical Devices

Certified ISO13485 auditor

Cosmetics, Biocides or Food supplement

IT knowledge

Job description

Perrigo Company is seeking a Quality Assurance Associate to manage QA activities for Perrigo Medical Devices products, including CMOs, and to support the Quality Management System across development, validation, and regulatory compliance. The role emphasizes collaboration with cross-functional teams in a fast-paced, global environment.

The ideal candidate has 8–10 years in life-science and medical devices, with 5+ years in QA, and strong knowledge of ISO13485 and MDR.