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Sr. Quality Engineer

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The company

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.

Role description

- 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.

Responsibilities

See above

Requirements

- 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®

Listed by: SIRE Life Sciences®
Listed on: 20-07-2017
Country: The Netherlands
Region: Noord-Holland
Employment: Freelance
Expertise: 3 - 5 years
Location Type: On location
Language: English
Sector: Medical Devices
Specialisation: Quality

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Contact

SIRE Life Sciences B.V.

Mondriaan Tower
Amstelplein 52, 25th floor
1096 BC Amsterdam
+31 (0) 20 658 9800

SIRE Life Sciences Belgium BVBA

Science 14 Atrium
14b, Rue de la Science
1040 Bruxelles
+32 (0) 2 588 1277

SIRE Life Sciences Deutschland GmbH

Fünf Höfe
Theatinerstraße 11
80333 München
+49 (0) 89 3803 8966

SIRE Life Sciences Maastricht

ROOOMS Maastricht
Boschstraat 21
6211 AS Maastricht


SIRE Group GmbH

Platz 3
6039 Root
Luzern
+41 (0)43 508 1743

SIRE Staffing Solutions

Keizersgracht 420 C
1016 GC Amsterdam
+31 (0) 20 658 9804

SIRE Information Technology

Calypso Building
Kruisplein 480
3012 CC Rotterdam
+31 (0) 10 316 1066

SIRE Healthcare

Mondriaan Tower
Amstelplein 52, 25th floor
1096 BC Amsterdam
+31 (0) 85 044 4640

SIRE Finance

Mondriaan Tower
Amstelplein 52, 25th floor
1096 BC Amsterdam
+31 (0) 85 044 4630

SIRE Engineering

Calypso Building
Kruisplein 480
3012 CC Rotterdam
+31 (0) 10 316 6626

SIRE Human Resources

Mondriaan Tower
Amstelplein 52, 25th floor
1096 BC Amsterdam
+31 (0) 85 044 4620

SIRE Staffing

Mondriaan Tower
Amstelplein 52, 25th floor
1096 BC Amsterdam
+31 (0) 85 044 4650

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