QA/RA Specialist

3 weeks ago

Stockholm, Stockholm, Sweden TN Sweden Full time

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QA/RA Specialist (parental leave cover), StockholmClient:

RaySearch Laboratories AB (publ)

Location:

Stockholm, Sweden

Job Category:

Other

EU work permit required:

Yes

Job Reference:

5566e82a284a

Job Views:

3

Posted:

15.03.2025

Expiry Date:

29.04.2025

Job Description:

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, Asia and Australia & New Zealand. 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.

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

The position is based at our office in Stockholm and is a one-year parental leave cover (direct employment with RaySearch) starting in May 2025 to May 2026.

About the role

As one of our QA/RA Specialists, you will join a team of ten dedicated coworkers. The role requires previous experience from maintenance of Quality Management Systems (QMS), including document management, CAPA management and change management. The QA/RA team is central to the company's business as it is responsible not only for the QMS but also for product market clearances, vigilance and internal and external audits. Since the pandemic, the team has grown from seven to eleven members and is expected to continue to grow.

As QA/RA Specialist, you will report to the Quality & Regulatory Affairs Director and be involved in all areas of the department.

  • Manage the project for transitioning our QMS from one digital platform to another
  • Manage the CAPA process and coach the organization regarding management of individual CAPAs
  • Assist our IT department in validating tools supporting the QMS
  • Assist with internal audits, external audits and inspections

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 supplied to markets worldwide. You will have contact with all departments at our headquarters and work closely with an international team happy to share knowledge.

Your profile

To be successful in this role you work in a very structured and meticulous way. You have an interest in QMS related tasks (e.g. document management, CAPA management, change management and tool validation) and experience from project management. You adapt to changing conditions and have good communication skills. 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.

Skills and experience:
  • Knowledge of ISO 13485, MDR or QSR
  • Flexible
  • Meticulous
  • Structured
  • University degree or equivalent
  • English at a high business level

It's an advantage, but not required, if you speak Swedish and have experience from software industry.

Our Culture

Culture at RaySearch is the driving force behind our organization, where everything we do is driven by a shared passion for innovation and the fight against cancer. Our dedication is reflected in our ability to deliver exceptional results, pay close attention to detail, and consistently go the extra mile. Our employees stand out as experts in their field, driven by a relentless focus on solving problems - no matter how complex. At RaySearch, we take pride in leading the way in cancer treatment, leveraging cutting-edge technology to develop innovative solutions that make a real difference in patient care.

Our Offer

At RaySearch, we offer a diverse and inclusive work environment, fostering openness, sincerity, and collaboration. Located in Hagastaden, Stockholm's Life Science Hub, our modern and creative workspace includes an in-house gym, yoga, and social activities like ping pong, table football, and regular after-work events. Our bistro serves a fantastic lunch buffet, and we offer morning- and afternoon-fika every day. Our rooftop terrace also provides a stunning 360-degree view of Stockholm, enhancing the work experience. All of this comes attached with a competitive compensation and benefits package.

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.

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