Quality Specialist

RaySearch Laboratories; Stockholms kommun; On-site; SEK 650,000 - 780,000; Full time

Job summary

RaySearch Laboratories seeks a Quality Specialist to join our Quality & Regulatory Affairs team in Stockholm. You will help maintain and improve our QMS, ensuring regulatory compliance for our software medical devices and related products.

You will collaborate across teams to support audits, drive continuous improvement, and balance quality with business needs using a pragmatic, risk-based approach. English proficiency and strong communication are essential.

Qualifications

• 3+ years of experience working with Quality Management Systems in the medical device industry.
• Bachelor's or Master's degree in Engineering, Life Sciences, Medical Technology, Quality Management, or related field.
• Good understanding of quality processes such as: CAPA, Non-conformities, Change control, Internal audits, Management reviews.
• Knowledge of ISO 13485 and medical device regulatory requirements.
• Experience from software medical devices is highly desirable.
• Strong communication and collaboration skills.
• Ability to work independently and drive activities forward.
• Able to balance compliance requirements with business needs using a risk-based mindset.
• Very good command of English, both spoken and written.

Responsibilities

• Support the maintenance and continuous improvement of the Quality Management System (QMS), related quality processes, and electronic QMS platforms.
• Manage and support CAPA, non-conformity, and change control activities.
• Plan, conduct, and follow up on internal audits.
• Support external audits, inspections, and supplier audits as needed.
• Support the management review process and quality performance monitoring.
• Review quality records and documentation to ensure compliance with company procedures and regulatory requirements.
• Support process improvements and help drive a culture of continuous improvement throughout the organization.
• Provide guidance and support to colleagues on quality processes and QMS requirements.

Skills

Quality Management Systems

ISO 13485

Medical device quality

English proficiency

Communication & collaboration

Risk-based mindset

Independent work

Regulatory understanding

Education

Bachelor's or Master's degree in Engineering, Life Sciences, Medical Technology, Quality Management, or related field

Job description

Do you want to contribute to improving the care of cancer patients by helping ensure the quality and compliance of innovative software medical devices?

Join RaySearch and become part of our Quality & Regulatory Affairs team. In this role, you will work closely with colleagues across the organization to support and continuously improve our Quality Management System, enabling the development and delivery of safe and effective products to patients around the world.

About The Role

As a Quality Specialist, you will be part of a dedicated Quality & Regulatory Affairs team supporting a growing and innovative medical device organization.

You will be involved in a variety of quality activities across the product lifecycle and have the opportunity to work closely with colleagues throughout the organization.

The role focuses on maintaining and improving our Quality Management System while supporting the organization in meeting regulatory and quality requirements in a practical and efficient way.

Your main responsibilities

• Support the maintenance and continuous improvement of the Quality Management System (QMS), related quality processes, and electronic QMS platforms.
• Manage and support CAPA, non-conformity, and change control activities.
• Plan, conduct, and follow up on internal audits.
• Support external audits, inspections, and supplier audits as needed.
• Support the management review process and quality performance monitoring.
• Review quality records and documentation to ensure compliance with company procedures and regulatory requirements.
• Support process improvements and help drive a culture of continuous improvement throughout the organization.
• Provide guidance and support to colleagues on quality processes and QMS requirements.

Your profile

We are looking for someone who enjoys working in a collaborative environment and combines strong quality knowledge with a pragmatic and positive mindset. You are proactive, structured, and detail-oriented, while also understanding how to apply quality requirements in a practical way that supports business objectives.

You are comfortable challenging the status quo, asking questions, taking ownership of issues through to completion, and making informed decisions when balancing quality, compliance, and business needs. You enjoy collaborating across functions, are eager to learn, and are motivated by continuous improvement.

Skills And Experience

• 3+ years of experience working with Quality Management Systems in the medical device industry.
• Bachelor's or Master's degree in Engineering, Life Sciences, Medical Technology, Quality Management, or a related field.
• Good understanding of quality processes such as:
• CAPA
• Non-conformities
• Change control
• Internal audits
• Management reviews
• Knowledge of ISO 13485 and medical device regulatory requirements.
• Experience from software medical devices is highly desirable.
• Strong communication and collaboration skills.
• Ability to work independently and drive activities forward.
• Able to balance compliance requirements with business needs using a risk-based mindset.
• Very good command of English, both spoken and written.
  

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 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.