QUALITY ASSURANCE (QA) SPECIALIST

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

Benefits offered by this job

Public transport reimbursement

Pension scheme

Health insurance

Sports allowance

Yoga classes

Dutch classes

28 holidays per year

Year-end closure

Job summary

MRC Holland, based in Amsterdam, is seeking a QA Specialist to manage QA processes within our ISO 13485 certified quality system. You will collaborate with RA, QC, Product Development and Technical Support to ensure regulatory compliance and continuous improvement.

This role is part of a 4-person QA team reporting to the QA Manager. The candidate holds a BSc in Biology or related field with at least 3 years in medical devices or biotech sectors and strong English communication skills.

Qualifications

• BSc degree in Biology, Biomedical Sciences or equivalent.
• 3+ years of relevant working experience in the medical device, pharmaceutical and/or biotech industries.
• Fluent written and spoken English; Dutch language is not required, but preferred.

Responsibilities

• Own and update QA procedures; Train functionaries; Monitor and provide trend-analysis of QA procedures as input for Management Review.
• Work and assist 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.
• Collaborate with interdisciplinary teams to stimulate and support continuous improvement.
• Lead and support QA-related projects.

Skills

QA processes

Nonconformities

Document Control

Analytical skills

English language

Team collaboration

Organizational skills

Regulatory knowledge

Education

BSc in Biology/Biomedical Sciences

Job description

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!

QUALITY ASSURANCE (QA) SPECIALIST (32-40 h/wk)

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 (responsible for Nonconformities and Document Control)
  • 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
• 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
• 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: €4284-€4561 per month.
• 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 weekly in one of our in-house yoga classes or Dutch classes.

Interested?

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.

The vacancy will close on November 28th. You can expect a response after this date.