Quality Management Specialist - Hamburg, Deutschland - Olympus Europa SE & Co. KG (OEKG)

Olympus Europa SE & Co. KG (OEKG)

Geprüftes Unternehmen

Hamburg, Deutschland

vor 2 Wochen

Geschrieben von:

Lena Wagner

beBee Recruiter

Responsibilities:

Support business units and functions in creation, implementation and maintenance of processes and related documented information.
Coordination of CAPA projects and handling of the NC process.
Plan and conduct internal management systems audits in a multisite environment at our EMEA subsidiaries. Follow up the corresponding corrective actions and support the Olympus EMEA organisation during external audits.
Conduct quality audits at supplier side for 3rd party products and outsourced processes.
Facilitate risk management sessions (FMEA)
Give trainings with regard to the quality management system
To be based in Hamburg office

Your qualification

University degree or similar qualification
Proven knowledge of ISO 9001:2015 / ISO 13485:2016 and Medical Device Regulation (MDR). Knowledge of 21 CFR Part 820 is a plus.
Experienced qualified auditor
Business driven attitude
Excellent communication skills; be able to effectively communicate across all levels of the EMEA organization and work productively with others in a team environment
Fluent English and German language skills. Further languages skills are a plus
Risk management knowledge is a plus
Flexibility and willingness to travel (<25%)

Your benefits