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Quality Assurance Manager for Central Europe Munich Germany,  

Posted on : 27 March 2017

Project Description

Tracking Code 10192-446 Job Description Provides leadership and strategic direction for the Quality Management System in compliance with European and FDA requirements for in-vitro diagnostic products. Implementation and maintenance of local Quality Management System in accordance with the Global RA/QA strategy and in compliance with European and FDA requirements. This includes among other things systems and processes for:   Quality Improvement Document Control Audits CAPA Nonconforming Products/OOS Change Control Complaint Handling Design Control Risk Management Management Review   Batch Record Review and Batch Release Offer quality related training for Munich site Execution of internal audits as lead auditor for the site Quality contact for authorities and notified bodies Management of notified body or authority audits Required Skills Analytical (thinking) skills Independent working style Fluent English-speaking     Required Experience Bachelor’s or Master Degree in Science A minimum of eight 8 years, with direct responsibility for Quality Management Systems and related compliance to current Quality Systems Regulation and other relevant standards (e. g. ISO 9001).  Knowledge of QMS requirements applying to in vitro diagnostic products Quality Engineering and /or Six Sigma Black Belt certification preferred. Job Location Muenchen, , Germany Department Reg.Affairs & QA CE(790) Position Type Full-Time/Regular


Muenchen Germany

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