Freelance QA Design Engineer - the Netherlands
Function Group: Quality/RA / QA Engineer
QTC Recruitment is currently looking for a Freelance Quality Design Engineer for a project of initially six months, with an option to extend. Broad quality systems, product design and medical devices experiences are needed.
Our client is a great innovative medical devices company based in the Netherlands.
For this role, we are looking for a highly experienced QA Design Engineer, who will provide expertise within the R&D and quality teams, and can ensure regulatory compliance. You will be working within an international environment and will have a key position within this team. You will be required to work with minimal supervision, and need little to no guidance in the further development of the quality management systems and different R&D processes.
- Develop and support the quality management systems according to the ISO13485 and FDA standards. Specifically, you will be working on the CAPA system, continuous improvements and the audit system
- Review and approve the design related documents
- You will be responsible for all the project related documents
- Responsible for (process) validation and related tests, and you will work closely with other relevant disciplines and departments for reviewing and approving relevant documentation
- Risk management
- Approve quality documentation in relation to design assurance projects
For this role you need the following requirements:
- Bachelor or Master degree in engineering, quality/regulatory or a similar discipline
- 10+ years of relevant experience in a similar role
- Extensive medical devices experience
- Broad knowledge of ISO13485 standards, FDA 21CFR820 and other relevant standards
- Strong analytical skills
- Extensive QMS experience, having a proven track record in quality process improvement
- Excellent English communication skills
- Being able to work independently and with minimal supervision is an absolute must
- You have great attention to detail, specially in oral and written communication
- Experience with “active medical devices” would be a great asset
Project for initially six months, with a possibility to extend. Immediate start date and excellent rates!
Do you see yourself in this role and do you have the required skillset? Please get in touch via email@example.com or +31(0)6 4254 0855.