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Quality Director

priority vacature priority vacature


Leadership position / unique opportunity to build the QMS for a new production site
(Almelo/Amersfoort, The Netherlands)

Het bedrijf / The company

The Surgical Company is a successful, worldwide operating, and innovative company in the field of Patient Temperature management which employs approximately 370 employees. The core activity of the Surgical Company is to keep patients at a constant healthy and comfortable body temperature. They offer a combination of complementary therapies necessary to prevent patients from the onset of peri-operative hypothermia. In the past few years, the Surgical Company has established the #2 market position and they sell their products B2B to more than 45 countries worldwide, with an ambition to grow further. To meet its growth plan, the company is investing heavily in the development of a new manufacturing facility with automated processes, located in Almelo. This new site will also include the warehousing/shipping activities for all The Surgical Company products. To make sure everything related to QMS and QA/QC processes are up and running by the time the site is ready for production, they are looking for an entrepreneurial Quality Director.

De functie / The role

As a Quality Director you will be responsible for the quality management strategy (QMS) and QA, QC and RA processes for The 37Company, including those related to product design. You will ensure the processes needed for the QMS are established, compliant, implemented and maintained. In order to do so, you are able to keep an overview and know which steps are required to build a QMS and will report on the performance of the QMS to top management including areas of improvement. Further, you are responsible for assuring that systems in place are adequate for manufacturing compliant products and you also capture and address non-conformances in a timely manner and implement comprehensive CAPA’s plans. Besides this you will maintain and implement improvements associated with procedures, systems, controls, reviews, Incoming Quality Control and In-process and Finished Goods Quality inspections and/or testing. You will lead and provide technical expertise in the validation, verification and qualification of products and processes used. As a Quality director you will act as a Management Representative as named in ISO 13485 and are responsible for audits. In this position you will lead and manage the QA/QC team (approximately 8 fte). You will be part of the management team and will report dotted line to the Site-Director and black-line to Global RAQA. Naturally, you will work closely together with global RA based in Amersfoort.

Het profiel / Your profile

• Bachelor’s Degree
• at least 5 years of experience in QA and managing a team
• experience in a production environment
• experience in medical devices is a big advantage
• knowledge of project management methodologies and tools
• strong communication skills, relationship builder, leadership qualities, able to keep an overview, good planning skills, pragmatic, hands-on

• strong communication skills (written and spoken) in both English and Dutch

Het aanbod / The offer

• unique opportunity to make a crucial quality contribution to a new production site (set up the QMS)
• opportunity to build your own team
• leadership position in an international, growing, and successful medical devices company
• dynamic and ambitious working place at a medium sized company
• innovative, lively, and ambitious environment with great opportunities

Reactie / Reaction

Interested? Please send your resume and motivational letter by e-mail, with reference WS/20-049-DD to info@derksenderks.nl. For further information, please call Djamila Hagemans or Anneke Aangeenbrug at number +31 (0)33 472 80 87.

An individual assessment may be part of the selection procedure.

Our client has chosen Derks & Derks B.V. as recruitment agency for this assignment. We request therefore to send any application or other response to Derks & Derks.

Solliciteer hier
Indien solliciteer hier u verwijst naar een ongeldig webadres, is de vacature (hoogstwaarschijnlijk) inmiddels vervuld. Attendeer FMF hierop

Uw referentie aan www.fmfvacatures.nl wordt gewaardeerd.
Your referral to www.fmfvacatures.nl is appreciated.



Derks & Derks
Derks & Derks
Almelo / Amersfoort

Geplaatst op FMF: 19 november 2020

Branche: Medical
Functie: QA / regulatory, Management
Opleidingsniveau: HBO / BSc, WO/academisch / MSc, PhD
Werkervaring: 5-10 jaar, > 10 jaar