QA Specialist – ISO 13485, Medical Devices

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, 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.