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Quality Engineer - Supplier Audit - Medical Device - Laboratory Automation

We recruit for a confidential Medical Device client. Our client is a Global Player and has more than 80 years experience in the field of Lab Automation. Client's 60,000 associates serve customers in more than 125 countries and generated $16.5 billion of revenue in 2016. Client's systems, found in hospitals and other critical care settings around the world, produce information used by physicians to diagnose disease, make treatment decisions and monitor patients. Scientists use the life science research instruments to study complex biological problems including causes of disease and potential new therapies or drugs.

This challenging position is located in Munich:

Quality Engineer - Supplier Audit - Medical Device - Laboratory Automation

- Establishing and monitoring supplier KPI’ s
- Establishing and implementing a supplier audit schedule
- Leading supplier audits
- Preparing and implementing material qualification protocols
- Developing and overseeing adherence to control plans for bought in materials
- Driving supplier performance improvement through root cause analysis, corrective action and supplier performance reviews
- Provide expertise and general support to the Manager Manufacturing Quality – Munich in the achievement of their objectives
- Ensure compliance with the European Medical Device Directive and associated regulations
- Liaise with the regional and global Q&R organization to support the development of and ensure alignment with client's global policies and procedures
- Support the application of client's tools throughout EMEAI

- University Degree in Engineering or equivalent
- Minimum of 5 years’ experience in supplier quality management in the field of medical devices, automotive, aerospace industry or with background in electro-mechanical equipment production
- Fluent in English and German– written and verbal
- ISO 13485 or ISO 9001 Lead Auditor

- Experienced and skilled at
- Leading change
- Managing supplier relationship programs
- Influencing without authority
- Negotiating
- Results Driven and customer orientated

- Solid working knowledge of EU, FDA and related regulations including QSR’s, (FDA 21 CFR 820), ISO 13485, ISO 14971 and the EU IVDD, Experienced in teaching others (preferred)
- Experienced in working within multi-functional, multi-regional teams (preferred)

If you are interested and qualified, please send us your resume as a Doc, RTF or PDF-File in English.
Kategorie Ingenieur Ansprechpartner BANDAO Unternehmensberatung GmbH
Mr. Markus Moser
Schloßbergstraße 1
D-82319 Starnberg
Tel. :+49-8151-555 1 666
Markus Moser
Branche Medical Device
Einsatzort München
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