QMS Manager - RaySearch Laboratories

RaySearch develops innovative software solutions to improve cancer care. Over 800 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, Asia and Australia & New Zealand. Today we are more than 380 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.

Do you want to improve the care of cancer patients by introducing new medical device software to all major markets? Join RaySearch and our QA/RA team and contribute to make the best cancer treatments available for patients all over the world.

About the position

As QMS Manager, you will join a team of seven dedicated coworkers. You have long experience from developing and maintaining a modern, international Quality Management System for medical devices, and have experience from the European MDD/MDR or the USA QSR.

The QMS Manager is a strategic position for RaySearch. Our high-paced software development, delivery and support of medical devices puts high demands on process control and documentation. You will enable for the entire organization to work in a compliant, structured manner, and at the same time, efficiently.

This is a full-time position at RaySearch’s head office located in Stockholm. The QMS Manager reports to the QA/RA Director and is involved in all work at the department and cooperates with key persons throughout our global organization.

Your main tasks

Quality

• Development of the QMS to meet changing business needs.
• Maintenance and continuous improvement of the QMS.
• Plan and manage external and internal audits.
• Oversee and continuously improve CAPA workflows.
• Manage documentation, both strategically and hands-on.
• Supervise and further develop the internal training program.
• Manage subsidiary support and guidance.

Regulatory

• Keep the QMS compliant with updated regulatory requirements and requirements from new markets.
• Help out with regulatory submissions when needed.
• Stay up to date with applicable standards and laws.

The role is a great opportunity for you to contribute to the care of cancer patients by enabling new software innovations to be quickly and reliably introduced in markets worldwide. You will have contact with authorities, subsidiaries and distributors and work closely with an international team happy to share knowledge.

Your profile

To be successful in this position you can both listen to others and tell them what to do. You have an interest in supporting others in finding the right work flows and explaining how to stay compliant to regulations. You work in a structured and meticulous way. It is essential that you are well-organized but can be flexible when required. You recognize the importance of written processes and instructions and take initiatives to fill in any missing pieces. You can work independently and like to share your knowledge with colleagues.

Requirements:

• University degree, or equivalent, in relevant field
• Experience from a similar role at a medical device manufacturer
• Very good knowledge of ISO 13485, QSR and/or MDD/MDR
• Experience from managing CAPAs and internal audits
• Fluent in English

It’s an advantage, but not required, if you also have experience of software development, designing workflows in databases and hosting external audits.

Application

Please apply to the position through the application form below. Selection and interviews will be ongoing. We do not accept applications by e-mail, but if you have any questions about the position please contact the recruiting manager David Hedfors (QA/RA Director) or Alinne Andersson (HR).