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23.03.2016

Sr Quality Assurance Engineer

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 Biotechnology and Medical Devices organization, based in Noord-Brabant Netherlands.

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

ROLE DESCRIPTION

My client is looking for an enthusiastic and dedicated Quality Engineer. In this small and close knit company, the ambition in the team is endless and you will be responsible for guiding this ambition together with good quality of processes and products.

RESPONSIBILITIES

- 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

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

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Onno Goedhart.



 
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