Quality Assurance Specialist — ISO 13485 & Audits (NL)

Physiol; Vierpolders; Remote; EUR 60,000 - 90,000; Full time

Job summary

Physiol in the Netherlands is seeking a Quality Assurance Specialist to maintain and improve the QMS in compliance with ISO 13485 and other regulatory standards. You will support product and process changes, ensuring regulatory alignment and proper documentation.

The role requires 3+ years in QA or regulatory, fluency in Dutch and English, on-site presence in Vierpolders five days a week, and a proactive, detail-oriented mindset for continuous improvement.

Qualifications

• Bachelor’s or Master’s degree in Engineering, Biomedical Sciences, Chemistry, or related field.
• 3+ years of experience in a Quality Assurance or Regulatory role, ideally in medical devices or another regulated industry.
• Knowledge of ISO 9001 is required; ISO 13485 experience 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.
• 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.

Responsibilities

• Maintain and continuously improve the Quality Management System (QMS) in compliance with ISO 13485 and other 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; 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 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.

Skills

Quality management

Regulatory compliance

Auditing

Training

Analytical thinking

Education

Bachelor's or Master's in Engineering/Biomedical/Chemistry

Tools

ISO 13485 Lead Auditor

Job description

Physiol in the Netherlands is seeking a Quality Assurance Specialist to maintain and improve the QMS in compliance with ISO 13485 and other regulatory standards. You will support product and process changes, ensuring regulatory alignment and proper documentation.

The role requires 3+ years in QA or regulatory, fluency in Dutch and English, on-site presence in Vierpolders five days a week, and a proactive, detail-oriented mindset for continuous improvement.