QUALITY ASSURANCE (QA) SPECIALIST (36-40 h/wk)

Mrcholland; Amsterdam; Hybrid; EUR 48,000 - 51,000; Full time

Benefits offered by this job

28 holidays a year

Public transport reimbursement

Pension scheme

Excellent health insurance

Sport subscription reimbursement

Job summary

MRC Holland, an Amsterdam-based biotech company, seeks a QA Specialist to manage QA processes within the ISO 13485 framework. You will help ensure regulatory compliance, support product development, and drive continuous improvement in a multinational team.

The role requires a BSc in biology or related field, 3+ years in medical devices or biotech, and strong English skills. We offer a comprehensive package and a stable, collaborative work environment.

Qualifications

• BSc degree in Biology, Biomedical Sciences or equivalent.
• 3+ years of relevant working experience in the medical device, pharmaceutical and/or biotech industries.
• Adequate knowledge of ISO 13485, ISO 14971 and related quality and risk management standards.
• Adequate knowledge of genetics.
• Fluent written and spoken English; Dutch is not required but preferred.
• Well-developed analytical skills.
• Affinity with procedures and processes.
• Pragmatic, pro-active and self-motivated.
• Strong organizational skills; able to manage multiple tasks and work both independently and in a team.

Responsibilities

• Process owner of certain QA processes, implementing and updating QA procedures.
• Training of functionaries and monitoring QA procedures with trend-analysis input for Management Review.
• Collaborate with other QA processes and participate in product design reviews as part of a Design Team.
• Handle Product/Batch Release and Internal Auditing.
• Collaborate with interdisciplinary teams to drive continuous improvement.
• Lead and support QA-related projects.

Skills

Fluent English

Analytical skills

Organizational skills

Self-motivation

Proactive attitude

Teamwork

Attention to detail

Education

BSc degree in Biology/Biomedical Sciences or equivalent

Job description

QUALITY ASSURANCE (QA) SPECIALIST (36-40 h/wk)

at least 36 hours per week

4,284-€4,561- per month (based on 40 hours)

MRC Holland has been paving the way to copy number confidence for over a decade. As the inventors and manufacturers of MLPA ® ,digitalMLPA ™and aMelt Assay for newborn screening, we supply the world with simple solutions to genetic inquiries.

As a successful, growing biotechnology company located in Amsterdam, the Netherlands, we offer a young, dynamic, and multi-national working environment. If you are passionate about providing the world with simple and affordable solutions to detect genetic aberrations, and enjoy a vibrant, family-friendly work environment: come join our team!

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
  • 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
• A 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
• 3 + years of relevant working experience in the medical device, pharmaceutical and/or biotech industries
• 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: €4,284-€4,561 (based on 40 hours contract). 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.