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Quality Consultant Medical Devices

Michael Bailey Associates - Amsterdam

Posted on Jun 11, 2021 by Michael Bailey Associates - Amsterdam

Eindhoven, Noord-Brabant, Netherlands
Health Care
Immediate Start
Annual Salary

Quality Consultant Medical Device

This is an exclusive opportunity for a Senior Quality Specialist to work in an innovative Quality Systems department for an international medical device manufacturer. This manufacturer is a global player when it comes to the external manufacturing of its products. The ideal Senior Quality Specialist will be responsible for ensuring quality system improvements and being a change agent compliance to medical device products internationally. Your team will comprise of 19 people in the quality department including quality assurance and quality control.

Senior Quality Specialist responsibilities:

  • Supports maintenance of quality systems and external applications

  • Evaluation of medical devices and Site Qualification activities for new product launches

  • Supports management of metrics for Site Qualification department

  • Provide quality systems support

  • Support the development and implementation of improved quality reporting measures

  • CAPA quality system records on behalf of the department

  • Support inspection readiness plans and Hosts during compliance audits and regulatory inspections on ATC-related matters, as needed

  • Participates in the development, implementation and maintenance to optimize department procedures; writes and implements controlled documents, as needed

  • Works with a cross functioning team eg R&D, Operations, Servicing and Marketing

Senior Quality Specialist requirements:

  • At least 4 years in a Quality function with experience in medical devices

  • MSc or relevant educational background in life science or related study

  • Fluent in English - Dutch is a bonus

  • Quality system support in the following areas: CAPA, Audit, Change Control, Training, Product complaints, Validation, Risk Management, Document control and Metrics reporting

  • Comfortable in a fast-paced expanding company environment

  • Honest, reliable and a great communicator

  • Knowledge of ISO 9001, ISO 13485, 21 CFR 820 or 21 CFR 11 is preferred

If you are interested in Senior Quality Specialist position, call me or email your CV

Michael Bailey International is acting as an Employment Business in relation to this vacancy.

Reference: 1225616671

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