Jobangebot: Quality Manager Project Design / Risk Management in PLZ 79***

A Day in the Life:
– QA-Project Manager, who acts as main interface to Design Control / Product development with full responsibility for small scale up to bigger projects;
– Oversees and implements ISO 13485, ISO 14971, MDSAP and QSR requirements;
– Supports and improves the CAPA- and Non-Conformity Handling processes;
– Acts as Subject Matter Expert for FMEA (FMECA) processes;
– Supports further Risk Management and Complaint Handling activities, acts as Bridge Person to Risk Management and PPI / Lean-activities;
– Acts as Lead Auditor for internal audits and prepares/supports all external audit activities;
– Collect user requirements for future EDMS Solution as replacement of current DOCAN and PCM/Remedy systems;
– Establish next generation of Quality Dashboard / Key Performance Indicators.

Keys to Success:

– University degree/certificate Life Science, Biology, Medicine or equivalent

– Several years of experience in Quality Management, preferred in the regulated industries; also, in Design and Development Projects;
– Lean management and FMEA background;
– Background as auditor (internal + external);
– Experience in IT applications, preferred EDM-Systems and Excel;
– Experiences with CAPA and Continuous Improvement Processes, 8-D Problem solving and Risk Management according ISO 14971.

Knowledge, Skills, Abilities
– Excellent Project-, Risk Management and Communication Skills;
– Fluent German and English (written and spoken);

What we offer:
– Employment with an innovative, future-oriented organisation
– Outstanding career and development prospects
– Company pension scheme and other fringe benefits
– Exciting company culture which stands for integrity, intensity, involvement and innovation


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    * - Pflichtfelder