QA Specialist – ISO 13485, Drive Biotech Quality

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

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.