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Quality Assurance Engineer / Pharma / Medical Devices / Validation/ 16 months

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The company

Our client is a professional Pharmaceutical and Medical Devices organisation, based in Noord-Brabant Netherlands. Our client is a professional Pharmaceutical, Medical Devices and Biotechnology organisation, based in Noord-Brabant Netherlands. Our client has also a site in Groningen, this site is the Center of Excellence for the development of innovative solutions for the surgical ophthalmic market, mainly intraocular lenses (IOLs). The site is responsible for the design and manufacture of these products. A project has started to further develop IOL manufacturing technology with a high degree of automation. Therefore, the Quality Department is looking for a Quality Assurance Engineer – Validation oriented.

Your work location will mostly be in Eindhoven with a trip to Groningen once every fortnight. Exciting isn't it?

Role description

As a QA Engineer you have a good working knowledge of the applicable regulations regarding the development and production of medical devices, in line with the Medical Devices Regulation, 21CFR Part 820 and ISO 13485 and ISO 14971.

You have a close loop approach to quality, like working in teams and projects, are result driven, while having a pragmatic and critical attitude that ensures that the site is in compliance and delivers products of high quality.

Responsibilities

Your responsibilities as a Quality Assurance Engineer:

- Support the key quality representative in multidisciplinary team working on a process development project, ensuring compliance. Review and approve project documentation.
- Ensure correct validation processes application (IQ/OQ/PQ/Test Method Validation) via proactive support, and review and approval of documentation.
- Support, perform and assess statistical analyzes and support in the implementation of statistical process control techniques, sampling schemes and other quality techniques
- Ensure that the change control procedures are correctly applied

Requirements

The requirements to be successful for this role are...

- At least 5 years of relevant work experience preferably in the pharmaceutical or medical device industry;
- A relevant Bachelor or Master of Science degree (technical, life science or related);
- Working knowledge of validation of equipment/processes is a must
- Working knowledge of Computerized systems, statistics, risk management, change control a strong plus
- Knowledge of relevant Medical Device regulations (GMP, MDR, QSR CFR 820, ISO 13485, ISO 14971) is considered a strong plus
- Self-starter, result driven, able to function independently as well as in a team;
- Able to work towards sound solutions in complex or seemingly conflicting situations; Flexibility and accuracy;
- Good communicative skills, excellent command of the English language and preferably the Dutch language;
- Knowledge of MS Office;

Other information

This is a project for approx. 16 months, based on 40 hrs a week. Full time preferred, 32 hours minimal. Work location mostly Eindhoven with a trip to Groningen once every fortnight. English required, Dutch considered a plus. Please include a motivation letter. Role is fixed-term (project based)

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


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SIRE Life Sciences®

Ref. number: 47493
Listed by: SIRE Life Sciences®
Listed on: 25-04-2019
Country: The Netherlands
Region: Noord-Brabant
Employment: Freelance
Expertise: 3 - 5 years
Location Type: On location
Education: Bachelor
Language: English
Sector: Medical Devices
Specialisation: Quality

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