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Sr. Quality Engineer

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L'entreprise

Our client is a professional Medical Devices organization, based in Noord-Holland Netherlands. Medical Devices company looking for a Sr. QA Engineer for a project of 6-12 months on site. Available in less than 2 weeks time would be great.

Description du rôle

- Maintain the CAPA (Corrective and preventive actions) system;
- Maintain the complaint handling system;
- Investigate deviations and NCR’s (non-conformances), by determining the root cause and implementing corrective and preventive action;
- Analyze data concerning production, processes and the quality management system and propose improvements;
- Release products, processes and equipment based on statistical data;
- Execute internal and external audits including reports.

Responsabilités

See above

Exigences

- Coaching and Management capabilities
- Good Manufacturing Practice
- Quality Management Systems (ISO13485. FDA 21CFR820, MDD 93/42EEC or similar)
- EO sterilization
- Cleanrooms/ microbiology
- Process validation
- Knowledge of Lean Six Sigma tools and project management
- Organized and structured way of working
- Customer focused and accurate
- Good judgement; showing business acumen, quality, perspective and problem solving.
- Thinking in solutions, socially skilled.
- At least 5 years professional experience
- Experience in Leading a Team and Auditing
- Experience in Regulatory and Customer focused organization
- Experience in a Pharmaceutical and/or Medical Devices company.



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SIRE Life Sciences®

Placé par: SIRE Life Sciences®
Posté le: 20-07-2017
Pays: The Netherlands
Région: Noord-Holland
Emploi: Free-lance
Compétence: 3 - 5 années
Type de lieu: Sure place
Langue: Anglais
Secteur: Dispositifs médicaux
Spécialisation: Qualité

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