Quality Assurance Manager

A global medical device manufacturer specializing in innovative vascular technologies is seeking an experienced professional to join its Quality team. The role offers an opportunity to contribute to both Quality Management and Regulatory Affairs at a key production site. The position reports directly to the senior leadership within the Quality department and involves cross-functional collaboration on a global scale.

Responsibilities :

• Manage and continuously improve the Quality Management System in compliance with ISO 13485, MDR, and applicable international regulations
• Draft, review, and authorize standard operating procedures (SOPs), work instructions, and quality documentation
• Oversee processes related to CAPA, change control, deviations, and non-conformities
• Ensure production processes meet regulatory requirements (MQA) including ISO 13485, MDR, and FDA standards
• Guarantee product design compliance (DQA) through design controls, verification activities, and documentation audits
• Lead and support internal / external audits, including those by regulatory bodies and clients
• Maintain and update technical documentation for medical devices
• Contribute to global regulatory submissions and approval efforts (e.g., MDR, FDA)
• Collaborate with manufacturing teams on process validation, risk assessments (e.g., FMEA), and in-process controls
• Provide internal training and regulatory guidance across departments
• Coordinate with international headquarters on quality and regulatory initiatives

Requirements :

• Minimum BSc in Engineering or equivalent field
• Proven experience in a regulated medical device or life sciences environment
• Deep knowledge of MDR, ISO 13485, 21 CFR Part 820, and technical documentation standards
• Proficiency with eQMS
• Fluency in German and English, both written and verbal