Product Quality Manager

About the role

The Product Quality Manager is responsible for ensuring that all products meet the highest quality standards throughout the manufacturing process. This role works closely with production, R&D, and regulatory teams to maintain compliance with GMP, ISO 9001 and ISO 13485 requirements.

Key responsibilities

• Supervise production documentation, batch records and quality files.
• Lead validation and qualification activities for processes, equipment and measurement methods.
• Manage CAPA, non‑conformities, root‑cause analysis and corrective actions.
• Conduct internal audits and support external audits.
• Oversee change control, product transfers and release of raw, semi‑finished and finished goods.
• Develop, review and maintain quality procedures, work instructions and records.
• Train laboratory technicians and production staff on quality standards and best practices.
• Ensure compliance with GMP, GDP and hygiene standards in line with ISO 9001 and ISO 13485.

Required profile

• Engineering diploma in Quality or equivalent.
• Minimum 5 years of experience in quality management, preferably in the medical device sector.
• Strong knowledge of ISO 9001, ISO 13485 and GMP requirements.

Required skills

• ISO 9001
• ISO 13485
• Good Manufacturing Practice (GMP)
• CAPA management
• Validation and qualification
• Internal and external audit execution
• Change control procedures
• Root‑cause analysis (RCA)
• Documentation and record management