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(Senior) Quality Engineer

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The company

Our client is a professional Medical Devices organization, based in Netherlands. My client is located in the area of Eindhoven. The company is a very promising Medical Devices company with highly innovative products.

Role description

- Maintaining ISO 13485 and FDA 21 CFR Part 820 related QA system, processes and procedures
- Planning and conducting quality system related trending and reporting
- Providing guidance and support in managing change controls, CAPAs and life cycle management of documents
- Supporting in filing submissions to FDA, Notified bodies, Competent Authorities and Ethical Committees for Medical Devices
- Conducting internal and supplier audits
- Providing support for the teams in respect to compliance with internal and external RA/QA requirements
- Be the Management Representative
- Supervising activities in document control and release activities
- Final product release

Responsibilities

See above

Requirements

- An engineering degree, preferably in biomedical engineering, or similar education level
- Minimum of 5 years work experience in medical device or pharmaceutical industry or equivalent, minimum 3 in quality-related functions
- In-depth understanding on quality systems and regulated processes, esp. according to ISO 13485, MDD 93/42/EEC and 21 CFR 820
- Experience in internal audits and quality system audits by Notified Bodies
- Ability to understand processes and identify critical gaps and areas for improvement
- Experience in clean room work environment
- Ability to communicate, train and provide guidance
- Fluent in English
- Certified as auditor a plus



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SIRE Life Sciences®

Ref. number: 23811
Listed by: SIRE Life Sciences®
Listed on: 20-07-2017
Country: The Netherlands
Employment: Permanent
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 UK

702 Howard House Dolphin Square
SW1V3PQ London
+44 7307 179882

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 440A
1016 GD 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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