(Senior) Quality Manager

(Senior) Quality Manager

Location: Koblenz, Rhineland-Palatinate, Germany (Hybrid)

Overview:

We are partnering with an innovative, family-owned company with over 1,000 employees, currently seeking a (Senior) Quality Manager to join their newly established division focused on bringing cutting-edge products to the medical device market.

Benefits:

1. Attractive Remuneration : Benefit from a competitive package that reflects your skills and contributions and generously rewards your hard work.
2. Work within a specialised development team : Help to bring their innovative health patches to market and work within a dedicated team to achieve success.
3. Permanent Full-Time Position : Permanent employment in an innovative, family-run company with a strong sense of social responsibility.
4. Responsible and varied tasks that allow you to have an enjoyable and varied job
5. Flexible Working: benefit from flexible working conditions and home office arrangements (2 days per week after probation)
6. 30 Days’ Vacation

Your Responsibilities:

• Serve as a key point of contact for quality matters across all departments, suppliers, customers, and executive leadership.
• Develop, implement, and continuously improve product and process development processes for medical devices, ensuring compliance with applicable regulations (MDR, FDA) and standards (EN ISO 13485).
• Actively contribute to product development initiatives, with a focus on compiling and structuring technical documentation, particularly the risk management file in accordance with DIN EN ISO 14971.
• Coordinate closely with the Regulatory Affairs team to ensure international market access for our medical products, including the interpretation and application of relevant standards and regulatory changes in both the EU and U.S. markets.
• Plan, execute, and follow up on audits (internal, external, and supplier audits), ensuring readiness and compliance across quality systems.

Your Qualifications:

• A technical or business degree, or completion of a technical training program with certification as a quality manager or equivalent credentials.
• Minimum of five years of practical experience in quality management, within the medical device field.
• Familiarity with quality standards such as EN ISO 13485 and DIN EN ISO 14971; hands-on auditing experience is a plus.
• Practical experience working with regulatory bodies, certification organizations, sales partners, and customers is advantageous.
• Experience supporting or leading development projects within the medical device industry is preferred.
• Solid understanding of project management principles.
• Competent in the use of MS Office tools and quality management-related software solutions.
• Strong communication skills in both German and English.
• A proactive, solutions-driven mindset and the ability to work independently to implement quality improvements.

For more information, please contact Luke Fines:

luke.fines@adaptivelifescience.com

+49 30 1663 4514