Manager QA GMP Compliance

Belgium, Alken

The Datwyler Group is a leading supplier of bespoke sealing solutions to global market segments, such as Healthcare, Automotive, Civil Engineering and Consumer Goods. This is built on leading material, engineering and process know-how and the worldwide presence with own production locations. With a global manufacturing footprint on three continents, sales in over 100 countries, and more than 7,000 employees, we generate an annual revenue in excess of 1.2 billion. Looking back onto more than 100 years of history, we are a reliable partner, now and in the future.

To support the growth in the Healthcare segments we are looking for a (M/F):

The position
You will manage internal as well as external (customers, notified body, …) Quality Audits. For external audits, this includes managing the audit planning, leading the audit (acting as the Datwyler representative), facilitating the plant tour, writing audit responses, following up on the CAPA’s and helping to further improve related processes.
For internal audits this includes training of the qualified internal auditors, managing the audit planning, leading internal audits, improving the audit process etc.
You will be part of the global Supplier audit team and lead supplier audits.

Additionally, you will define and agree upon customer specific quality agreements and specifications. This means that you will join customer meetings , complete Quality related questionnaires, review and approve quality agreements and specifications and assure proper implementation of the agreements

Areas of responsibility
You will contribute to the quality management at the production site in Belgium by ensuring compliance with internal and external Quality standards (eg applicable ISO standards, GMP, global standards) .

Profile
You have a master degree and min. 3 years of relevant QA experience in a GMP environment. You have knowledge of relevant standards and legislations (eg ISO9001, ISO15378, GMP, FDA etc.).
You like to be in contact with customers and to work closely together with people in different areas (sales, operations, procurement etc.). You have strong communication skills and are fluent in Dutch and English, verbal and written.
You have a pro-active attitude and you are process- and improvement oriented.

We offer you the opportunity to utilize your work experience and implement your innovative ideas in a specialized, future-oriented company. In case you are interested please send your application to jobs.be@datwyler.com

Datwyler Sealing Solutions
www.datwyler.com

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