Medical Device Quality Assurance Expert
Vor 5 Tagen
This is a fantastic opportunity to become part of a rapidly growing digital health company based in Germany. Specializing in minimally invasive neurostimulation products, the company is revolutionizing the market with its innovative approach. With their recently launched product gaining significant traction, they are now seeking an experienced Quality Manager with extensive SaMD expertise to drive their continued success.
Responsibilities:
- Evaluating the effectiveness of the quality management system, including management review and quality objectives
- Processing complaints, implementing corrective and preventive measures
- Supporting internal, external, and supplier audits
- Ensuring quality assurance and quality control throughout product development processes, focusing on software life cycle processes
- Risk management
- Maintaining post-market surveillance for products
- Evaluating regulatory changes and updates
- Continuously improving and maintaining the established quality management system in accordance with ISO 13485, MPDG, and MDR 2017/745/EU requirements
Requirements:
- Bachelor's degree in a scientific field
- At least 5 years of experience in the medical device industry, preferably in active (implantable) medical devices or software for medical devices
- Basic understanding of medical device approval processes, including EU and FDA regulations
- Good knowledge of relevant standards and regulatory requirements, such as ISO 13485, ISO 14971, ISO 62304, and IEC 81001-5-1
- Familiarity with MDR, MPDG, and 21CFR820 desirable
- Understanding of change management and transformation principles
- Fluent English language skills, with German language skills being a plus
The successful candidate can expect a competitive salary of €80,000 - €110,000 per year, depending on experience. This position offers an exciting opportunity to contribute to the growth and success of a dynamic company in the digital health sector.
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