Quality Assurance (QA) Specialist (32-40h/week)

As a QA Specialist at MRC Holland, you are responsible for the development, implementation, coordination, monitoring and management of one or more specific QA processes of the ISO 13485 certified quality management system. You assist in ensuring that MRC Holland and its products meet standard and regulatory requirements. This function requires understanding and knowledge of the ISO 13485 and related quality and risk management standards applicable to In Vitro Diagnostics and Research Use Only products. Also, you provide advice and guidance to MRC-staff concerning quality. You collaborate with different departments within the company (RA, QC, Product Development, Technical Support, etc.) on projects and you make sure processes are aligned. You are part of the QA Team which currently consists out of 4 colleagues and you report directly to the QA Manager.

Key Responsibilities

• Process owner of certain QA processes.
• Implementing and updating QA procedures (responsible for Change Control, Discontinued Products).
  • Training of functionaries.
  • Monitoring and providing trend-analysis of QA procedures as input for the Management Review.
• Work and assist your colleagues in other QA processes.
• QA representative in product design reviews as part of a Design Team and responsible for QA-related design project deliverables and documentation.
• Product/Batch Release.
• Internal Auditing.
• Collaboration with interdisciplinary teams to stimulate and support continuous improvement.
• Leading and supporting of QA related projects.

Qualifications

• BSc degree in Biology, Biomedical Sciences or equivalent.
• 1-3 years of relevant working experience in the medical device, pharmaceutical and/or biotech industries..

Required competences

• Adequate knowledge of relevant industry quality and risk management standards (e.g. ISO 13485, ISO 14971) and basic knowledge of relevant international regulations regarding IVDs (e.g. European IVD Regulation (EU 2017/746)).
• Adequate knowledge of genetics.
• Fluent written and spoken English (Dutch language is not required, but preferred).
• Well-developed analytical skills.
• Affinity with procedures and processes.
• Pragmatic, pro-active and self-motivated.
• Strong organizational skills, flexible, ability to manage multiple tasks and attention to detail.
• Able to work alone as well as part of a team.

What do we have to offer?

We offer a great position in a medium-sized, flexible organization, where many people from different cultural backgrounds work, and where independence and professionalism are of paramount importance. Starting salary: €3550 - €4150. In addition, we have excellent employment conditions. At MRC Holland we have 28 holidays a year and are also closed between Christmas and New Year's Day. We have full reimbursement for travelling with public transport, an excellent pension scheme and extensive collective health insurance with reimbursement from MRC Holland. Finally, you will receive a reimbursement of max. €25 per month on your sports subscription, and you can participate in yoga classes or chair massage.

Interested?

Please send your cover letter and curriculum vitae apply@mrcholland.com. The same email address can be used for any questions. Only applications including a letter of motivation will be considered.

Only applicants who are currently residing in the Netherlands and possess a valid working permit will be considered. For more information on our company and products, see www.mrcholland.com.