QA Specialist — ISO 13485, On-site NL

Physiol; Netherlands; On-site; EUR 50,000 - 75,000; Full time

Job summary

Physiol in The Netherlands (Vierpolders) seeks a Quality Assurance Specialist to maintain and improve the QMS under ISO 13485. The role includes supporting new product introductions, managing non-conformities and CAPAs, and ensuring regulatory alignment.

You will plan and execute audits, train colleagues, and monitor quality metrics while collaborating across departments to drive continuous improvement on the production floor.

Qualifications

• Bachelor’s or Master’s degree (WO level) in Engineering, Biomedical Sciences, Chemistry, or a related field.
• 1–3 years of experience in a Quality Assurance or Regulatory role, ideally within medical devices or another regulated industry.
• Knowledge of ISO 9001 is required; experience with ISO 13485 is a strong advantage.
• Auditing experience or certification (e.g., ISO 13485 Lead Auditor) is a plus.
• Fluent in Dutch and English, both written and spoken.
• Available to work on-site in Vierpolders five days per week (full-time presence required).
• Strong analytical skills with high attention to detail.
• Proactive, quality-driven mindset with a focus on continuous improvement.
• Excellent communication skills and ability to collaborate effectively across departments.

Responsibilities

• Maintain and continuously improve the Quality Management System (QMS) in compliance with ISO 13485 and other applicable regulatory standards
• Support the implementation of new or updated products, processes, and procedures, ensuring regulatory and quality alignment
• Manage non-conformities, complaints, and CAPAs, ensuring thorough investigation, timely follow-up, and proper documentation
• Plan, coordinate, and conduct internal and supplier audits; actively support external audits and regulatory inspections
• Provide training and coaching to colleagues on quality standards, procedures, and best practices
• Contribute to Management Reviews and monitor key quality performance metrics, identifying improvement opportunities
• Review and approve production batch releases, validation protocols, and validation reports
• Provide hands-on quality support to operational teams on the production floor, ensuring compliance in day-to-day activities

Skills

Analytical skills

Attention to detail

Communication skills

Dutch language

English language

Education

Bachelor/Master in Engineering/BioSc/Chemistry

Job description

Physiol in The Netherlands (Vierpolders) seeks a Quality Assurance Specialist to maintain and improve the QMS under ISO 13485. The role includes supporting new product introductions, managing non-conformities and CAPAs, and ensuring regulatory alignment.

You will plan and execute audits, train colleagues, and monitor quality metrics while collaborating across departments to drive continuous improvement on the production floor.