For one of our clients focused on Medical Devices we are looking for an experienced freelance QA Engineer to join this young and vibrant company. The client is located in the Brabant area of the Netherlands. You will join the team for initially a few months. However, if all goes well, a permanent contract will be offered.
You will understand the processes used and will areas for improvement.
Maintain the quality systems and regulated processes (ISO13485, MDD 93/42/EEC, 21 CFR 820).
File submissions (for example FDA).
Provide support in change controls, life cycle management of the documentation.
Provide support with CAPAs.
You will be reviewing and approving validations.
You will train others and provide the necessary guidance.
You will perform audits, both supplier and internal.
Background in Engineering.
At least 5 years working experience in a regulated environment.
At least 3 years in full QA responsibilities.
Broad knowledge of applicable quality systems and regulated processes (ISO13485, MDD 93/42/EEC, 21 CFR 820).
Audit experience – it is a plus if you are certified.
Experience with clean-room.
Experience with process improvement – Six Sigma is a plus.
Fluent in English
6 months with possibility of perm contract
PROJECT START DATE
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