QA/RA Officer

QTC are partnered with a world leader in virtual reality robotics for human movement research and rehabilitation based in the Utrecht area. The business have over 20 years of experience in advancing rehabilitation technology driven by a state-of-the-art software framework.

Our client are looking for a QA/RA Officer on a permanent basis to support in implementing and maintaining quality systems whilst also supporting regulatory compliance across the product lifecycle. Activities include: Assisting in the development, implementation, and upkeep of quality management systems in accordance with relevant regulations and standards. Conducting internal audits to verify adherence to quality processes and identify areas for enhancement. Supporting establishing and maintaining Key Performance Indicators (KPIs) to monitor the performance of the Quality Management System (QMS). Supporting manufacturing and supply chain teams in managing nonconforming material, acceptance procedures, part qualification, and process validation. Assisting the QA/RA team in Corrective and Preventive Action (CAPA) activities as assigned. Facilitating the commercialisation of medical devices by obtaining and maintaining product registrations. Assisting in developing technical files to ensure ongoing global compliance with applicable product requirements. Providing advice on regulatory changes impacting product and business regulations.

Requirements:

• Minimum bachelor's degree in a technical field and at least 3 years experience in a quality management system (QMS) role.
• Demonstrated experience in quality assurance within the medical device or pharmaceutical industry.
• Thorough knowledge of relevant regulations and standards (e.g., FDA 21 CFR Part 820, ISO 13485, Regulation (EU) 2017/745).
• Strong analytical and problem-solving abilities.
• Excellent communication and teamwork skills.
• Preferred qualifications:
  • RAC Certification, ASQ Certified Quality Auditor (CQA), ASQ Certified Biomedical Auditor (CBA), or equivalent certification.
  • Experience with electronic quality management systems (eQMS).
  • Familiarity with statistical methods and tools.

Offer:

• Competitive salary and benefits package.
• Broad role with training across different expertise areas.
• Dynamic environment with a young team.
• Global development opportunities.