Beschreibung
Quality Assurance Manager (m/f/d)
Reference: -en
Start: asap
Duration: 11 MM++
Main tasks:
- Collaborate with R&D in support on the documentation creation for design, development of the device and design transfer to manufacturing for in-vitro medical devices
- Maintain oversight of quality documentation, including but not limited to design and development records such as design history files, regulatory submissions, device master record, device history file, change control, validations, methods, and technology transfer
- Ensure documents are thorough, accurate, and compliant to support regulatory inspections and submissions
- Provide support for investigations and recommend, develop and implement corrective actions
- Provide support during regulatory inspections and audit and responsible for overseeing and/or performing auditing efforts that seek to ensure compliance with regulatory guidelines
- Identify quality system improvements when gaps are identified through audits and departmental reviews.
- Proactively investigates and identifies improved quality practices.
- Report regularly to Department Lead
Main qualifications
- Strong knowledge in the ISO 13485 Quality Management System environment over the entire spectrum
- Strong knowledge and background in medical device regulated environment required
- Solid working experience in a 13485-quality controlled environment
- Requires advanced knowledge of professional field and industry. Influences the development of and drives the application of principles, theories, concepts and determines best course of action
- Experience with Medical Device related Standards such as ISO 14971, ISO 62304, ISO 62366
- Positive attitude: values others and works well independently and in a team environment
- Ability to work effectively in a high-pressure and dynamic start-up environment
Main advantages:
- Great place for rapid advancement
- Offers a promising opportunity to learn and share know-how in a very agile environment
About us:
With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.
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