Design Assurance Engineer - Heerenveen
Function Group: Engineering / Design Engineer
For an organisation that develops, produces and sells innovative equipment and application software for hospitals for the nuclear medicine and (radio) pharmaceutical industry, we are looking for a Design Assurance Engineer to strengthen the quality team.
Within this role you will work in a small quality team in which you will be responsible for providing input into the quality and R&D team to ensures that compliance to all regulatory requirements is demonstrated. Your tasks will be related to:
- Leading and participating in risk management and design review sessions with engineering teams
- Reviewing and approving of design and verification related documentation
- Maintaining technical documentation
- Management of all project related documents
- In close collaboration with other departments, guide the execution of (process) validations and associated tests
- Supporting the QMS with particular focus on CAPA system, continuous improvement activities, internal audit system
- Approving of design and quality documents related to design assurance and general quality management processes
We are looking for someone with the following skillset:
- HBO level
- Experience in 21CFR820 and ISO13485 quality systems regulations
- More than three years of experience in a similar role at a medical devices company or highly regulated industry
- Experience in product development and life cycle management (product maintenance), preferably with software development and/or hardware/systems development
- Strong communication skills throughout all levels of the organisation
- Fluent in English, written and spoken
This company offers a challenging job with high level of responsibility. The company has a relaxed work environment and offers a competitive salary and clear growth opportunities.
If you are interested in this job, or in similar ones, please feel free to contact me directly.
Consultant | Medical Devices
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