Quality Manager

Join CYTO365 and shape quality in MedTech solutions

CYTO365 is a Swedish MedTech company with a strong entrepreneurial spirit and a clear mission:
"Aid Nurses to Do Right".
We develop and manufacture innovative components for a global market, and our patented product RondelO is designed to prevent unintended drug mixing in IV infusion therapy.

We are now looking for a hands-on Quality Manager to take a key role in maintaining and continuously improving our Quality Management System and regulatory compliance as we grow.  

You will work closely with the team including management, sales, QA/RA Consultant, production, and external partners in a modern MedTech environment, including our newly built cleanroom facility in Helsingborg.   

Your Role

As Quality Manager, you will be responsible for quality assurance and regulatory activities throughout the product lifecycle, developing deep expertise in our products. You will also act as Management Representative according to ISO 13485.

Key Responsibilities

Quality & Development

• Participate in development projects for new products to ensure quality in product and process design at CYTO365 and at suppliers/subcontractors, in accordance with Design Control and ISO 13485.
• Plan, perform, and document tests (e.g. design verification), including test plans and reports.
• Change Control.

Production

• Establish, implement and maintain production processes.
• Maintenance and re-qualification of cleanroom.

Quality Management System (QMS)

• Maintain, and continuously improve the Quality Management System.
• Ensure that QMS processes are established, implemented, and maintained.
• Promote awareness of applicable regulatory and QMS requirements throughout the organization and assure compliance.

Management Representative Responsibilities

• Analyse and report the status of the QMS, processes and products in the Management Review process.
• Prepare documentation, compile data, and document Management Reviews.

Audits

• Plan and conduct internal audits.
• Perform supplier and subcontractor audits.

Regulatory Affairs & Compliance

• Establish regulatory requirements applicable to CYTO365 AB products and assure compliance.
• Establish regulatory requirements applicable to CYTO365's role as distributor of medical devices.
• Surveillance of regulatory documents such as standards and guidelines.
• Handle complaints and non-conformities, regulatory reporting of incidents and near incidents.
• Perform batch dispositions for CYTO365's products.

Your Profile

Required Qualifications:

• Documented experience in Quality Assurance.
• Risk Management.
• Proficient in MS Office.
• Excellent English skills, both written and spoken.
• Structured, detail-oriented, and quality-focused.
• Strong communication skills and ability to work cross-functionally.
• Proactive, independent, and comfortable working in a small team.

Preferred Qualifications:

• Documented experience from QA/RA work for medical devices.
• Trained in Medical Device regulatory requirements
• Solid knowledge of ISO 13485 Quality Management Systems and ISO 14971 Risk Management

What We Offer

• A key role in a MedTech company with innovative, patented products.
• Modern facilities including in-house cleanroom.
• Competitive benefits package including pension, insurance, wellness allowance, phone, and computer.
• Opportunity to influence and develop quality processes in an international environment.
• A collaborative culture in a small dedicated team with strong team spirit.

Applications

Please submit your
CV

and a brief
cover letter

describing your background and motivation no later than February 15, 2026. 

For questions regarding the role or recruitment process, please contact:

Micael Törnblom, CEO,

Anna Rydberg, CCO,