We are looking for a highly capable and pragmatic Group Manager Quality to play a key role in shaping the next phase of quality excellence at RaySearch Laboratories, supporting innovation in a medical device organization.


**About The Job**
This role is ideal for someone who combines deep quality and regulatory expertise with operational pragmatism - a leader who understands how to build lean, scalable, and fit-for-purpose quality systems that support both compliance and business growth.


You will have the opportunity to influence how quality operates across the organization, drive evolution of an established QMS, and implement efficient ways of working that enable the business to operate with both confidence and speed.


You will be part of the Quality & Regulatory Affairs Department, reporting to the Director of the Department, and lead a team of two direct reports.


Your main tasks



- Drive the continued evolution of the Quality Management System (QMS), with a focus on simplicity, scalability, and business enablement
- Strengthen and streamline quality processes to support efficient, high-quality operations as the organization grows
- Lead and develop the quality team, providing clear direction, coaching, and support
- Oversee key operational quality activities, including CAPA, nonconformance management, change control, internal audits, document management, and supplier quality
- Partner with cross-functional teams to ensure quality practices enable efficient and effective ways of working
- Support validation and compliance activities related to software systems and eQMS platforms, including contributing to the selection and implementation of a future eQMS solution
- Contribute to the development of quality and compliance processes in emerging areas such as AI, machine learning, and data management
- Ensure compliance with relevant regulatory frameworks, including ISO 13485, MDR Article 10, MDSAP, and QMSR
- Apply pragmatic, risk-based thinking to quality and compliance challenges, balancing regulatory requirements with business needs

Your profile


You are a pragmatic, collaborative leader with a strong focus on continuous improvement. You understand what good quality looks like and how to implement it in a way that supports, rather than slows down, the business.


You are comfortable operating in evolving environments, able to distinguish between critical risks and unnecessary complexity, and motivated by building strong cross-functional relationships.


Most importantly, you are motivated by the opportunity to make a visible impact and help shape a modern, scalable quality organization.


**Experience & Skills**

- MSc or BSc in engineering, life sciences, or a related field relevant to medical device quality and regulatory affairs
- Extensive experience in Quality Management within the medical device industry
- Strong expertise in ISO 13485, MDR, MDSAP, and QMSR
- Strong understanding and practical application of ISO 14971 risk management principles for medical devices
- Proven leadership experience with direct people management responsibilities within the medical device, biotechnology, or pharmaceutical manufacturing industries
- Lead auditor experience, including planning, conducting, and leading internal and external audits
- A hands-on leader who enjoys improving processes and solving operational challenges
- Experience implementing or optimizing eQMS solutions is highly valuable
- Experience with medical device design and development processes, including software lifecycle processes under IEC 62304, is highly valuable
- Minimum of 5 years of experience in Quality Management within the medical device industry
- Very good command of English, spoken and written
- Lead Auditor certification is beneficial

Our Culture


At RaySearch, we share a passion for innovation and the fight against cancer. Our team consists of dedicated experts who strive to deliver exceptional results through collaboration, attention to detail, and cutting-edge technology. We take pride in our role as a leader in cancer treatment, developing solutions that truly make a difference for patients worldwide.


Our Offer


We offer a dynamic and inclusive work environment in Hagastaden, Stockholm’s Life Science Hub. Our modern office space includes an in-house gym, yoga classes, and social activities such as ping pong, table football, and after-work events. We also provide a fantastic lunch buffet, daily fika, and a stunning rooftop terrace with a 360-degree view of Stockholm. This comes with a competitive compensation and benefits package.


Application


Please apply for the position through the application form below. We do not accept applications via e-mail.