For our partner, a Robotics Medical Device company in the Eindhoven area, I’m looking for a (Sr.) QA Manager. This company is on a mission to improve patient’s lives through developing robot systems for microsurgery.
As QA Manager you’ll manage and improve the QMS, guide the company to MDR and maintain good relationships with the relevant authorities. In this position you’ll directly report to the CEO.
You’ll work in a vibrant research and manufacturing environment to realise the industralisation of their revolutionary microsurgical robots together with a driven team.
- Manage and optimise the QMS in compliance with the ISO13485
- Introduce and implement the quality processes and tools required to ensure product quality
- Guide the company from MDD CE certificate to MDR CE certificate
- Develop working knowledge of associated business initiative regulations and act as a voice for regulatory requirements. At the same time act as support for regulatory changes
- Establish and maintain good working relationship with regional Notified Body (DEKRA)
- Internal- and external audits, CAPAs, NCRs, Product/ process verification and validation
- Release of products for clinical use and studies & Review technical reports and documentation
- Act as representative (towards patient safety and MDR/ QSR regulations) to ensure QA and RA compliance
- Minimum of Bachelor’s Degree in technical area or other relevant scientific fields
- At least 5 years of industry experience (High Tech e.g. Robotics, Mechatronics, Electronics, Software)
- 5+ years’ experience with Quality Assurance of Class IIa, IIb or III devices
- Working knowledge of ISO13485, ISO14971, ISO60601, ISO62304 FDA QSR, MDD, MDR
- Able to work per priorities and tight deadlines in a fast paced, time sensitive environment
- Fluent in English, reading and writing
- Good communication, reliable, independent, goal-oriented, solution minded, pragmatic attitude
ORGANISATION AND OFFER
The company is focused to improve patient’s lives through developing robot systems for microsurgery. They have an excellent dynamic team with proven track records in the commercial, clinical and technical domain and have strategic collaborations with clinical key opinion leaders, industrial and other partnerships and experts.
The organisation offers an attractive salary and benefits.
INTERESTED? Please contact for more information by contacting +31 (0)20 20 44 502 or firstname.lastname@example.org