Quality Consultant Medical Devices

€80 tot €81 per hour
Job Ref:

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 e.g 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 on +31 207 97 5005 or email your CV

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

Tel: 020 7739 2022
Contact: Billy Thomasson-Khan

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