Senior QA Officer
Fulltime
Location: Bilthoven, The Netherlands
Department: Quality Assurance
Join Kuros Biosciences and help advance the future of the future of orthobiologics for spinal fusion surgery. We’re looking for a Quality Assurance (QA) Officer to support our quality management and regulatory compliance activities related to product development and manufacturing of medical devices and biological products. This is a key position within our Quality Assurance team in Bilthoven.
About Kuros Biosciences
Kuros Biosciences is a Swiss-listed life science company specializing in orthobiologics for spinal fusion surgery. With locations in Switzerland, the USA, and the Netherlands, we manufacture our bone repair products in Bilthoven and sell them worldwide. We are seeking an experienced Senior QA Officer to join our growing Quality Assurance team in Bilthoven.
Position Overview
As a Senior QA Officer, you will support the development, implementation, and maintenance of Kuros’s Quality Management System (QMS) in accordance with ISO 13485, FDA 21 CFR 820, GMP, GDP, and cGMP requirements. You will play a vital role in ensuring product quality, regulatory compliance, and continuous improvement across the organization.
Your responsibilities will include supporting supply chain team and the life cycle management teams to be performed in a compliant manner according the quality and regulatory requirements, preparing and reviewing quality procedures and documentation, conducting internal and supplier audits andcoordinating quality improvement initiatives.
Key Responsibilities
Quality Assurance
- Write, review, and approve quality procedures and related documentation.
- Support document control and training systems, ensuring proper revision control, traceability, and compliance.
- Plan, perform, and report internal and supplier audits.
- Support supplier qualification, including review and approval of supplier quality documentation.
- Conduct staff training on QA-related topics, including regulatory standards and production activities.
- Maintain QA databases and quality indicators (e.g., deviations, complaints, corrective/preventive actions).
- Coordinate change control and support continuous improvement within the QMS.
- Participate in product development and risk management projects as the QA representative.
- Support regulatory submissions and product approvals (e.g., CE marking, 510(k)).
- Facilitate and participate in external audits and inspections by regulatory authorities or customers.
- Maintain knowledge of applicable standards and regulatory requirements, ensuring timeliness and compliance of updates.
Safety, Organization, and Productivity
- Comply with all Kuros safety standards and hazard procedures.
- Contribute to the evaluation and introduction of new procedures, supplies, and equipment.
- Support training and mentoring of colleagues and trainees.
- Use resources efficiently and responsibly.
Qualifications and Experience
Education
- Bachelor’s degree in Life Sciences (e.g., Biology, Biomedical Sciences) or a technical field (e.g., Chemistry, Physics), or equivalent qualification (Dutch HLO/HBO level).
Experience
- Relevant QA experience in medical devices, pharmaceuticals, or biological products manufacturing (onsite or outsourced).
- Solid working knowledge of ISO 13485, ISO 9001, cGMP, or FDA 21 CFR 820 (QSR), MDSAP.
- Experience with (cleanroom) production environments is a strong advantage.
- Ability to work independently and as part of a cross-functional team.
Skills
- Strong command of English (written and spoken).
- Excellent communication and interpersonal skills.
- Knowledge of US/EU Medical Device and/or Pharmaceutical regulatory frameworks.
- Strong attention to detail, accuracy, and problem-solving mindset.
Key Competencies
- Attention to detail – thorough and precise in all aspects of QA work.
- Effective communication – clear and professional in both written and verbal interactions.
- Proactive and persistent – drives actions and improvements with determination.
- Accurate and reliable – ensures high data integrity and documentation quality.
Why Kuros Biosciences?
Join an international, innovative company with a diverse and energetic team. At Kuros, you’ll work in a positive and collaborative environment, contributing to the development of life-changing products. We offer great benefits, a competitive salary, and opportunities for career growth.
