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Quality Assurance Engineer / Medical Device

Quality Assurance Engineer / Medical Device

 

Role purpose

·       Support and improve quality system management in compliance with applicable requirements  (ISO 9001, ISO 13485, QSR 21 CFR 820, …) and promote continuous improvement process

·      Represent the quality department on production site

·       Support Production Engineering team with process validation

·       Support any improvement project from quality perspective

·       Participate to third parties audits (Bodies notified, authorities, ISO 13485, FDA, etc.),

·      Promote quality system and approach in the company.

 

Generic job description

·       Support and improve quality system management in compliance with applicable requirements (ISO 9001, ISO 13485, QSR 21 CFR 820, …)

·       Promote continuous improvement process ( non-conformity, CAPA and Change management)

·       Process validation

·       Follow-up of production non-conformities

·       Participate to third parties audits (Bodies notified, authorities, ISO 13485, FDA, etc)

·       Manage the Continuous Improvement Plan

·       Promote quality system and approach in the company.


Profil

·      Knowledge of  the requirements relative to the ISO13485, European directive 93/42 and 21 CFR part 820

·       Continuous improvement

·       Good skill for communication and coordination

·       Knowledge of the usual computing tools

·       Conscientious

·       Diplomat

·       Rigorous

 

Adresse

Rue Malatrex 38 1201 Genève

Website http://www.swissels.com