Senior Quality Engineer

uur

Eindhoven

€4000,- tot €5300,- Per maand

Solliciteren

In het kort

For our client, an ambitious medical technology scale-up located in the Eindhoven region, we are looking for a Senior Quality Engineer. After a decade of intensive R&D, they are on the verge of bringing their first, groundbreaking Class III medical devices to market.

Over de functie

As a Senior Quality Engineer, you will play a key role in the transition from R&D to production. You will ensure that their processes and products meet the highest quality standards. Your tasks include:

Managing Non-Conformities (NCs) and Corrective and Preventive Actions (CAPAs).
Reviewing and approving Change Controls.
Maintaining and continuously improving the Quality Management System (QMS) in accordance with ISO 13485.
Playing an active role within Operations to support in-house production and the associated supply chain.
Playing an active role within R&D to support product development, including reviewing plans, reports, and applying Design Controls.
Supporting the Quality Control (QC) department, particularly around batch release.

Please note: in-depth expertise in both R&D and Operations is not a requirement; a strong foundation in one of these domains is sufficient.

Kwalificaties

A completed technical HBO (higher professional education) or WO (university education) degree.
Minimum of 5 years of work experience in a Quality Assurance or Quality Engineering role.
Experience within the medical device industry (Class II or III) or the pharmaceutical industry.
In-depth, demonstrable knowledge of and experience with ISO 13485.
Experience with QMS maintenance, Change Control, and managing NCs & CAPAs.
Excellent command of the English language, both verbally and in writing.

Aanbod

Our client offers you the unique opportunity to play a key role in a crucial phase of their company. Your contribution is directly visible and essential to their success.

This is initially a temporary position for 6 months (for at least 32 hours per week). With successful collaboration and mutual fit, there is a clear intention to convert the role into a permanent contract. The company offers a competitive salary and the flexibility to work partly from home, although they expect you to be regularly in the office at the beginning, to get up to speed quickly.

Over het bedrijf

The mission of this company is to make a significant difference in patients' lives with their technology. They are in a crucial growth phase, further professionalizing their quality system for market introduction in Europe and the US. Working with them means being part of a dynamic journey, where you directly contribute to a tangible product with enormous impact. The atmosphere is informal, pragmatic, and comparable to that of a start-up: they are flexible and switch gears quickly. <br />You will be part of the Quality department, a team of six professionals with a mix of Quality Assurance (QA) and Quality Control (QC). The QA team consists of three experienced colleagues. The team is diverse in background and personality, which creates a dynamic and educational environment. The working language within the organization is English.

Contact

Ben je enthousiast over deze functie of heb je nog vragen?

+31 61 07 75 912

anouk@asqrecruitment.nl

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Direct contact?

BEL ONS:

+31 61 07 75 912

EMAIL ONS:

anouk@asqrecruitment.nl

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