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.