Group Manager Quality
RaySearch Laboratories AB (publ)Publicerad: 2026-05-29
Ansök senast: 2026-06-27
Beskrivning
RaySearch develops innovative software solutions to improve cancer care. About 1000 clinics in more than 40 countries use RaySearch software to improve treatments and quality of life for patients. RaySearch was founded in 2000 and is listed on Nasdaq Stockholm. The headquarters is located in Stockholm, with subsidiaries in the US, Europe and Asia - Pacific. Today we are more than 400 employees with a common vision of improving cancer care with innovative software. Our great staff is crucial for our success and we offer a fantastic working environment in modern offices, flexibility and good opportunities for development. We believe in equal opportunities, value diversity and work actively to prevent discrimination.
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.
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.
