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 Quality Manager to play a key role in shaping the next phase of quality excellence at RaySearch Laboratories, supporting innovation in a medical device organization.
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 three direct reports.
- Drive the continued evolution of the Quality Management System (QMS), with a focus on simplifying processes, enabling scalability, and supporting efficient, high-quality operations as the organization grows.
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Lead and develop the quality team, providing clear direction, coaching, and support
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Oversee key operational quality activities, including CAPA, nonconformance management, change control, internal audits, document management, and supplier quality
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Support selection and implementation of an eQMS solution
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Contribute to the development of quality and compliance processes in emerging areas such as AI, machine learning, and data management
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Ensure compliance with relevant regulatory frameworks, including ISO 13485, MDR Article 10, MDSAP, and QMSR
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Apply pragmatic, risk-based thinking to quality and compliance challenges, balancing regulatory requirements with business needs
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Partner with cross-functional teams to ensure quality practices enable efficient and effective ways of working
- MSc or BSc in engineering, life sciences, or a related field relevant to medical device quality and regulatory affairs
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Extensive experience in Quality Management within the medical device industry
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Strong expertise in ISO 13485 and medical device quality management systems, including experience with MDSAP and FDA QMSR requirements.
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Solid knowledge of the European Medical Device Regulation (EU MDR).
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Strong understanding and practical application of ISO 14971 risk management principles
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Lead auditor experience, including planning, conducting, and leading internal and external audits
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Proven leadership experience, including leading and developing teams
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A hands-on and pragmatic leader who enjoys improving processes and solving operational challenges
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Very good command of English, both written and spoken
- Experience implementing, optimizing, or validating eQMS solutions
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Experience with medical device design and development processes, including software lifecycle processes under IEC 62304
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Experience with Cybersecurity requirements for medical devices.
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Experience with AI/ML-enabled medical devices.
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Lead Auditor certification
You are a pragmatic, collaborative leader with a strong focus on continuous improvement. You have a clear sense of what good quality looks like and know how to implement it in a way that supports, rather than slows down, the business.
You are comfortable operating in evolving environments, with the ability to distinguish between critical risks and 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.
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.
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.
Please apply for the position through the application form below. We do not accept applications via e-mail.
