Germany | Competitive salary + Bonus + Benefits
For an international medical device company in Germany, we are looking for a hands-on QA/RA Manager to take ownership of the Quality Management System and support the organization’s ongoing MDR and ISO 13485 compliance.
This is not a people-management role. You will report directly to the Managing Director and have significant ownership and visibility within the organization where you will make an impact!
Your Responsibilities
- Own, maintain and continuously improve the QMS
- Ensure compliance with ISO 13485 and EU MDR
- Lead preparations for an upcoming external audit
- Maintain quality and regulatory documentation
- Support internal/external audits and CAPA activities
- Coordinate Regulatory Affairs activities with the RA Specialist
- Work closely with R&D and product development
Your Background
- 2–3+ years' QA/RA experience within Medical Devices
- Strong ISO 13485 knowledge
- Good understanding of EU MDR
- Hands-on QMS experience
- Experience with audits and regulatory documentation
- Proactive, pragmatic and comfortable taking ownership
- Fluent English; German is an advantage
What's Offered
- Bonus
- Home-office flexibility
- Fuel/travel expenses - Company car potentially negotiable
- Supportive, international and family-oriented working environment
Interested in a hands-on QA/RA position with real ownership and direct access to senior management?
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