QA manager - Medical Devices - R&D - Tilburg
Progressive looking for an experienced QA specialist in Medical Devices R&D departments. The company is based in the area of Tilburg and the project duration is about 4 months. Are you a talented quality professional looking for a temporary challenge in a healthcare environment? Please continue reading!
For this function, you have to maintain and assure the quality and safety of products, which can be medial and non-medical. Risk management, design quality assurance activities and coordination of these activities together with other departments are your key challenges.
What are your responsibilities?
- Accountable for Quality Management System
- Support Q&R compliance to assure products comply with QMS requirements
- Support, instruct and coach project teams on relevant product standards (IEC60335/IEC60601/21 CFR820/ISO13485, etc.)
- Review requirements management process to product verification and validation.
- Ensure risk management quality (quality of UFMEA, DFMEA, PFMEA/HB-SRA, etc.).
- Ensure compliance to quality system requirements, regulations and standards
What are the job requirements?
- You have either a bachelor degree with 5+ years of related experience or a Master degree with 3+ years of related experience.
- Strong knowledge of global medical device or consumer product regulations, and standards such as 21 CFR Parts 803, 806, and 820, ISO13485, and ISO9001.
- You have experience in a medical device industry.
- Strong communication skills: across teams and programs, from senior to administrative personnel. You have experience leading remote teams.
- You are detail oriented and able to see big picture
Are you available and interested in the role? Give me a call on +31 10 206 9888 or leave me a message! Should you know someone suitable for this function, do not hesitate to share with me!