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Manager Quality Assurance - Medical Device - IVD - 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:
 

Manager Quality Assurance - Medical Device - IVD - Laboratory Automation

 
Description
Working within the Workflow and IT Solutions (WITS) Quality & RA organization, the Manager Quality Assurance reports directly to the WITS Director, Quality & Regulatory Affairs. He/she ensures compliance of the products and the design process, including design changes to established products. S/he leads a team of quality engineers supporting Automation and Informatics product lines. He /she interacts collaboratively with the Product Compliance Group, to ensure the type testing certification such as electrical and electromagnetic compatibility and also compliance to product specific directives such as restriction of Hazardous Substances (RoHS) are in place, and with the Development Group to make sure that applicable standards are met (such as Software development lifecycles and Usability engineering). He is able to work in a matrix and multicultural environment to drive improvement and simplification. Thanks to his vision of Quality in a regulated environment he’s able to inspire and develop his team and to influence stakeholders in order to improve processes and maintain compliance.

Specific Responsibilities
- Leads and develops a team of Quality Engineers
- Ensures Design Control compliance
- Drives Design Validation and non-product software validation
- Coordinates Risk Management activities
- Drives improvement of local and global processes associated to design and development

Qualifications
- Bachelor/Master degree in sciences, life sciences, engineering, software development or equivalent education gained through work experiences.
- Successful experience in leading a QRA team in Medical device/IVD industry of 10 years +
- Excellent communication skills and team work
- Excellent practical experience of ISO9001, ISO13485 and 21 CFR part 820 Quality System Regulation
- Experience in design validation and generation of associated protocols gained either from in house testing simulating end use or actual end use in a clinical environment
- Computer skills (MS Office products)
- Knowledge of ISO14971, IEC 60601 / IEC 61010 3rd Edition, IEC 62366 and IEC 62304.
- Ability to work cross culturally/functionally and understand functional department requirements
- Proficient in English
- Excellent organizational capabilities
- Highly ethical, is able to multi-task and prioritize in a competitive environment
- Clean driving record – ability to travel as required (may include international travel).

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
Markus Moser
Schloßbergstraße 1
D-82319 Starnberg
Tel. :+49-8151-555 1 666
E-Mail: job@bandao.de
www.BANDAO.de
Markus Moser
Branche Medical Device
Einsatzort München
Beginn sofort
 
 
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