Job Title: Quality Manager
Location: Baden-Württemberg, Germany
Job Title: Full-time permanent
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
Please reach out to emily.james@skillsalliance.com for further information.