QA/RA Specialist

2 weken geleden

Delft, Zuid-Holland, Nederland NES Fircroft Voltijd € 45.000 - € 75.000 per jaar

NES Fircroft is looking for a QA/RA specialist to join an high-end technology supplier specializing in
medical technology, biotechnology, and in-vitro diagnostics
. Our client provide contract engineering and manufacturing services, covering the entire product development process from concept to production.

Responsibilities

  • Ensure compliance with international regulatory standards (e.g., ISO 13485, MDR, FDA 21 CFR Part 11) for medical devices.
  • Develop, implement, and maintain Quality Management System (QMS) processes and documentation.
  • Prepare and submit regulatory filings, technical documentation, and product registrations.
  • Conduct internal audits and support external audits from notified bodies and regulatory authorities.
  • Monitor and interpret changes in relevant regulations and standards, ensuring timely implementation.
  • Collaborate with cross-functional teams (R&D, Manufacturing, Clinical) to ensure regulatory and quality requirements are met throughout the product lifecycle.
  • Manage risk assessments, CAPA (Corrective and Preventive Actions), and non-conformance reports.
  • Support product labeling, IFU (Instructions for Use), and compliance with UDI requirements.
  • Provide training and guidance on quality and regulatory processes to internal teams.

Requirements

  • Bachelor's or Master's degree in Biomedical Engineering
    or similar.
  • Minimum 2–3 years of experience in QA/RA roles within the MedTech or medical device industry.
  • Strong knowledge of ISO 13485, EU MDR, and FDA regulations.
  • Experience with QMS implementation and maintenance.
  • Excellent documentation and organizational skills.
  • Proficiency in English (written and spoken); additional languages are a plus.

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