Vacancy: Quality Officer

1. Job Description

1.1   Challenge

Sirius Medical Systems B.V. is a fast-growing Medical Device scale-up with big ambitions. At Sirius Medical, we improve care for cancer patients through our effective, affordable localization system, enabling the precise and efficient surgical removal of tumors. We’re located at the High Tech Campus in Eindhoven, the Netherlands.

Having achieved a strong product-market fit and a successful early growth phase, we are on a mission to maximize our market footprint and to become a leading player in our market.

At Sirius Medical, we believe that diversity, equity, and inclusion are essential to our

growth, creativity, and success. We are committed to building a workplace where everyone feels respected, valued, and empowered to contribute fully. We strive to:

• Foster diversity: We welcome people of all backgrounds, identities, and experiences.
• Ensure equity: We aim to provide fair access to opportunities, support, and resources, recognizing and addressing barriers where they exist.
• Build inclusion: We create an environment where all team members feel safe, heard, and able to be their authentic selves.

Position overview

We are looking for a hands-on, initiative-taking Quality Officer to join our growing team. This role is designed to support our Quality team in maintaining and improving the Quality Management System and ensuring day-to-day compliance with applicable quality procedures and standards. The ideal candidate will provide hands-on assistance across departments in documentation, complaints, and operational quality activities. You will be part of our Quality team and support other teams when appropriate.

1.2   Responsibilities

Quality & Compliance

• • Maintain QMS documentation, e.g., by reviewing, formatting, publication, and document version control.
  • Participate in improvement activities and overall quality assurance support as needed.
  • Process and track change requests and ensure related records are complete.
  • Operational document control, compliance, and GDP (Good Documentation Practices) taking the librarian role for controlled documents and backups
  • Support the Service team with complaint handling and related documentation.
  • Escalate quality issues, complaints, or nonconformities to the Quality Manager and/or the Management Team.
  • Support Supply Chain (e.g., incoming goods inspections, shipments).
  • Support equipment definition and qualification.
  • Provide administrative support during audits, reviews, and inspections.
    
    
    

2.   Profile

Must have

• You like working in a technical environment and enjoy rolling up your sleeves, but you are equally comfortable with accurate documentation and maintaining high-quality records.

• Excellent communication skills, with a customer-centric mindset.
• Comfortable working in English and Dutch in an international setting.
• 2+ years of experience in a quality-related role in a regulated environment (medical devices preferred).
• You are familiar with ISO 13485 and EU-MDR 2017/245.
• You have completed a technical HBO/WO degree, preferably in (bio)medical technology, mechatronics, or a related field. More important than your exact diploma is your combination of technical affinity and a structured, accurate way of working.

Nice to have

• Familiarity with MDSAP, 21CFR820, or other medical device regulations.
• Audit skills and certificates. 

3.   What do we offer?

• Meaningful work: Be part of a mission that truly matters - supporting surgeons and patients in their fight against cancer.

• Opportunity to work directly with and learn from the leadership team to make a direct impact on the company’s performance.

• Work in a flat, non-hierarchical, and low-bureaucracy environment.

• Flexible work environment (hybrid workplace possible).

• We value work-life balance and will provide flexibility to accommodate your circumstances where possible. 

Apply now