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The companyOur client is a professional Healthcare and Medical Devices organization, based in Limburg Netherlands. Medical Device company with its headquarters in the Netherlands.
Role descriptionThe company is looking to hire a consultant with Quality Medical Device experience for at least six months. Highly likely to be 12 months or even more. My client is currently occupied with a project which contains the streamlining of the different operating quality management systems within the company. Multiple projectteams are doing an inventory, building a new, or validation a new QMS. In this stage the company is looking for a Q&R person with medical device experience, and experience in reviewing and redesigning processes. Work with program and project teams from the business and Q&R to perform the review and incorporation of Quality System Regulations into the processes down to the level of work instructions.
Responsibilities- Create and write Quality Plan in collaboration with the different teams and Q&R department
- Defining the needs of the renewed Quality Management Systems
- Support of the overall program
- Supporting the GAP-analysis
- Supporting the projectteams
- Alignment between the Quality Plans, Verification & Validation Plans and deployment Plans
Requirements- 10 years plus experience in Medical Devices QA/RA
- Knowledge of FDA CFR 820, ISO 13485 medical devices regulations
- Expert on Quality Systems matters
- Software validation
- Validation skills (IQ,OQ, PQ)
- Can do mentality
- Commitment for longer period of time
- Handson experience