Quality Associate – Medical Device Manufacturing

About the role

The Quality Associate supports Quality Assurance and Quality Control activities at the Malaga site, ensuring the manufacture and release of safe, compliant, and high‑quality medical devices.

Key responsibilities

• Perform visual inspection and bioburden reduction of final products according to approved procedures.
• Coordinate sample preparation and shipment to external laboratories, maintaining traceability and documentation.
• Review batch manufacturing records for accuracy and compliance before batch release.
• Generate, issue, and control batch records and product labels for in‑process and final product activities.
• Support document control, internal and external audits, and quality investigations including CAPA.

Required profile

• Relevant qualification in Science, Laboratory Techniques, Quality, or Medical Device Manufacturing, or equivalent experience.
• Working knowledge of GMP, good documentation practices, and Quality Management System requirements.
• Strong attention to detail, analytical and problem‑solving abilities, and ability to manage multiple quality activities.

Required skills

• Visual inspection of medical devices.
• Bioburden reduction processes.
• Document control and batch record review.
• Internal auditing and CAPA investigations.
• Proficiency with GMP records and traceability systems.