Group Manager Quality

RaySearch Laboratories

Do you want to build something new, not just maintain what already exists? A lot is happening in RaySearch’s Quality & Regulatory Affairs department right now, and RaySearch is looking for a business-minded Group Manager Quality who will lead a team, shape the next phase of quality excellence and drive development forward in a medical device company where innovation and compliance go hand in hand.

About RaySearch

RaySearch Laboratories is a Swedish medical technology company that develops software for radiation therapy of cancer. Founded in 2000 and listed on Nasdaq Stockholm, RaySearch builds solutions such as the RayStation treatment planning system and the RayCare oncology information system, which are used by cancer clinics worldwide. The team is made up of dedicated experts who share a passion for innovation and for the fight against cancer. At RaySearch, you contribute to solutions that truly make a difference for cancer patients worldwide.

Your role

As Group Manager Quality, you lead the Quality function at RaySearch. You are part of the Quality & Regulatory Affairs Department, report to the Director of the department, and lead a team of three. This is a role with great opportunities to build new, influence and drive change. You will shape how quality works across the organization and evolve an established QMS into something lean, scalable and fit for purpose, so the business can move with both confidence and speed. From the selection of a new eQMS to quality processes for AI and machine learning, you will help set the direction. Your main responsibilities include:

Driving the continued evolution of the QMS, with a focus on simplifying processes and enabling scalability as the organization grows
Leading and developing the quality team through clear direction, coaching and support
Overseeing key operational quality activities, including CAPA, nonconformance management, change control, internal audits, document management and supplier quality
Supporting the selection and implementation of an eQMS solution
Contributing to quality and compliance processes in emerging areas such as AI, machine learning and data management
Ensuring compliance with ISO 13485, MDR Article 10, MDSAP and QMSR, and supporting regulatory inspections and audits
Partnering with cross-functional teams so that quality practices enable efficient ways of working

Your background

An MSc or BSc in engineering, life sciences or a related field relevant to medical device quality and regulatory affairs
Extensive experience in Quality Management in the medical device industry
Strong expertise in ISO 13485 and medical device QMS, including MDSAP and FDA QMSR requirements
Solid knowledge of EU MDR
Strong understanding and practical application of ISO 14971 risk management
Lead auditor experience, including planning, conducting and leading internal and external audits
Proven leadership experience, including leading and developing teams
Very good command of English, both written and spoken

It is meriting if you have experience implementing, optimizing or validating eQMS solutions. Experience with medical device design and development, including software lifecycle processes under IEC 62304, is also meriting, as is experience with cybersecurity requirements, AI/ML-enabled medical devices, or a Lead Auditor certification.

You are a business-minded, hands-on and collaborative leader who enjoys improving processes and solving operational challenges. You have a clear sense of what good quality looks like, and you know how to implement it so that it supports the business rather than slowing it down. You can tell critical risks from unnecessary complexity, and you naturally build strong cross-functional relationships. Most importantly, you are motivated by the opportunity to make a visible impact and play a key role in shaping a modern, scalable quality organization.

RaySearch offers

A key role at an exciting time, when a lot is happening in the Quality & Regulatory Affairs department
Great opportunities to build new, influence and drive development forward, and to lead a team shaping a modern, scalable quality organization with visible impact across the company
A modern office in Hagastaden, Stockholm’s Life Science Hub, with an in-house gym, yoga classes, a lunch buffet, daily fika and a rooftop terrace with a 360-degree view of Stockholm
A competitive compensation and benefits package