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The companyOur client is a professional Chemicals, Medical Devices and Pharmaceutical organization, based in Netherlands. My client develops and manufactures Medical Devices focust on the European market. With the end consumer in mind, they are focused on producing simple, innovative and affordable solutions for care aids for the elderly people.
Role descriptionAs the Quality Manager you will provide support on all quality related issues concerning the medical devices that my client manufactures. You will be the spokes person for the company regarding quality production problems and will supervise the QC of the labo. Together with our facility manager, you will implement and maintain the ISO certification with GMP, and will maintain other QMS systems within the company.
Together with the responsibilites for Medical Devices, you will be acting as the RP for the manufacturing department or at least have the aspirations to become one.
Responsibilities- Implementing and managing ISO13485 QMS
- Acting as QP
- Performing internal and external audits
- Ensuring CAPA actions are timely defined, documented, tracked and closed
- Supporting on quality related production issues
- Training and daily supervision of the quality team
- Improving production SOP's
- Set up quality specifications for New Product Development
Requirements- Minimum of bachelor in natural or applied sciences
- 5 years of work experience in Medical Devices and/or Pharmaceutical industry
- Proven experience in QA and/or QC
- Excellent knowledge of GMP
- Excellent knowledge of ISO13485:2016
- Experience in analytical chemistry
- Fluent in English, good knowledge of German
- High energy level
- Hands-on mentality
- Ability to adapt to constantly changing environment and work under pressure
- High level of accuracy
- Multi tasking and team player