QA Engineer Validation

Bedrijfsnaam: -
Plaatsingsdatum: 25/04/2019
Standplaats: -


SIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences 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!Our client is a professional Pharmaceutical organisation, based in Noord-Brabant Netherlands.The CompanyOur client based in Eindhoven started a project 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.

Role DescriptionAs 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• 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• 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 informationFull 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 Rutger Koning.




Plaatsingsdatum :
Referentienummer :
Standplaats :
Adres :
Postcode :
9723 HK
Opleidingsniveau :
Uren :
Nader te bepalen
Dienstverband :
Werkervaring :
3 - 5 jaar
Contactgegevens :