Quality Engineer

Manpower

Wrocław, dolnośląskie
Stała
Pełny etat

19 dni temu

Manpower (Agencja zatrudnienia nr 412) to globalna firma o ponad 70-letnim doświadczeniu, działająca w 82 krajach. Na polskim rynku jesteśmy od 2001 roku i obecnie posiadamy prawie 35 oddziałów w całym kraju. Naszym celem jest otwieranie przed kandydatami nowych możliwości, pomoc w znalezieniu pracy odpowiadającej ich kwalifikacjom i doświadczeniu. Skontaktuj się z nami - to nic nie kosztuje, możesz za to zyskać profesjonalne doradztwo i wymarzoną pracę!Duties:

Create and maintain quality management system procedures to support regulatory and quality compliance
Monitor, analyze, and improve the effectiveness of the quality management system
Develop corrective actions, solutions, and improvements
Provide regulatory advice and guidance throughout the complete product lifecycle: Requirements, Design, Verification & Validation, Commercialization and Maintenance
Conduct internal audits and ensure timely follow through on resolution of related audit findings
Support certification (e.g., ISO 13485), customer and other regulatory audits
Participate in the evaluation and approval of suppliers
Provide quality and regulatory related trainings

Requirements:

Master’s degree in engineering, scientific, or technical discipline
Working knowledge as Quality Engineer (or similar role) having contact with medical device regulatory or other regulated business
Practical experience with medical device standards such as ISO 13485, ISO 14971, IEC 62304 & IEC 62366
General computer and technical literacy and openess for acquiring new knowledge (Considerable knowledge of medical device software and/or hardware development and production – as an advantage)
Very good interpersonal, written, and verbal communication skills (English B2)

Offer:

Work in a fast moving and technologically advanced environment
Opportunity to gain knowledge in IT & healthcare sector
An excellent learning environment with prospects for career advancement
Referral bonus
Benefits package
Employment contract or B2B
Hybrid model of work

Permanent job offer.

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