Senior QA Officer

Kuros Biosciences; Bilthoven; On-site; EUR 50,000 - 70,000; Full time

Benefits offered by this job

Competitive salary

Opportunities for career growth

Collaborative work environment

Job summary

Kuros Biosciences, located in Bilthoven, is seeking a Senior QA Officer to support our quality management and regulatory compliance activities in advancing orthobiologics for spinal fusion surgery.

The ideal candidate will have a Bachelor's degree in Life Sciences and experience in medical device QA. Responsibilities include writing quality procedures, conducting audits, and regulatory support.

Join an innovative team with opportunities for career growth and great benefits.

Qualifications

• Relevant QA experience in medical devices or pharmaceuticals manufacturing.
• Solid working knowledge of ISO13485, ISO9001, and cGMP.
• Ability to work independently and in a cross-functional team.

Responsibilities

• Write, review, and approve quality procedures.
• Conduct internal and supplier audits.
• Support regulatory submissions and product approvals.

Skills

Strong command of English

Excellent communication skills

Knowledge of US/EU regulatory frameworks

Attention to detail

Education

Bachelor's degree in Life Sciences or equivalent

Job description

Fulltime

Location: Bilthoven, The Netherlands

Department: Quality Assurance

Join Kuros Biosciences and help advance 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 ISO13485, FDA21CFR820, 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 the supply chain team and the life cycle management teams to be performed in a compliant manner according to the quality and regulatory requirements, preparing and reviewing quality procedures and documentation, conducting internal and supplier audits, and coordinating 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., CEmarking, 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 ISO13485, ISO9001, cGMP, or FDA21CFR820 (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.

Benefits

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.