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(Senior) Quality Engineer

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SIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!

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


See above


- 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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