Quality Manager
A fantastic opportunity for a global organisation to support the set up of their start up subsidary! The ideal Quality Manager will be responsible for the below and must bring the following requirements.
Your Responsibilities:
- Lead the setup, implementation, and continuous improvement of product and process development systems for medical devices, ensuring compliance with EN ISO 13485, MDR, and FDA regulations.
- Serve as the primary point of contact for quality-related matters across departments, management, customers, and suppliers.
- Plan, conduct, and follow up on internal, external, and supplier audits.
- Collaborate on product development projects, especially in structuring and compiling technical documentation, including risk management files in accordance with DIN EN ISO 14971.
- Work closely with Regulatory Affairs to ensure global regulatory compliance and market readiness of medical devices, particularly in Europe and the USA.
Your Profile:
- Degree in engineering, business, or equivalent technical qualification, ideally with additional training in quality management.
- Solid knowledge of relevant standards (EN ISO 13485, DIN EN ISO 14971) and preferably audit experience.
- At least 5 years of experience in quality management, ideally within the medical device industry.
- Familiarity with project management and early-stage product development.
- Initial experience in regulatory communications with authorities, partners, and customers.
- Proficient in MS Office and quality management software tools.
- Fluent in German and English.
- Strong problem-solving skills, with a proactive and independent approach to finding and implementing solutions.
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