QA/RA Specialist

10 hours ago

Stockholm, Stockholm, Sweden RaySearch Laboratories AB (publ) - Stockholm Full time

Krav

  • Kvalitetskoordinator - erfarenhet efterfrågas

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.

Your main tasks:
  1. Manage the project for transitioning our QMS from one digital platform to another
  2. Manage the CAPA process and coach the organization regarding management of individual CAPAs
  3. Assist our IT department in validating tools supporting the QMS
  4. 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
  • Project management experience
  • 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.

#J-18808-Ljbffr

  • QA/RA Specialist

    1 week ago

    Stockholm, Stockholm, Sweden Raysearch Laboratories AB (Publ) Full time

    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...

  • QA/RA Ansvarig

    7 days ago

    Stockholm, Stockholm, Sweden Moveup Consulting AB Full time

    Vi är på jakt efter en talangfull QA/RA Manager som kan bidra till vår tillväxtresa inom cancervården. Rollen kräver en person som kan säkerställa kvalitet och regulatorisk efterlevnad i våra produkter.Uppdraget omfattar:Vidmakthålla teknisk dokumentation.Produktregistrering på nya marknader.Kvalitetskontroll, CAPA och...

  • Medical Device Specialist

    5 days ago

    Stockholm, Stockholm, Sweden TN Sweden Full time

    At RaySearch, we believe that quality and safety are essential to delivering exceptional results. Our QA/RA team is responsible for ensuring the quality and safety of our medical devices, from development to delivery. We work closely with regulatory authorities to ensure compliance with relevant regulations and guidelines.We are seeking a Medical Device...

  • Senior RA Specialist Med Tech

    7 days ago

    Stockholm, Stockholm, Sweden Bondi Chefrekrytering AB Full time

    About the Role:We are seeking a highly experienced Senior RA Specialist Med Tech to join our global quality and regulatory affairs team.Key Accountabilities:Be the main contact for RA activities, including participating in regular meetings with license partners.Develop, create, submit, and maintain product registrations for the company's products during new...

  • QA Specialist

    1 week ago

    Stockholm, Stockholm, Sweden Xensam AB Full time

    Xensam: SAM Disrupters Xensam is the leading provider of AI-powered, cloud-hosted Software Asset Management technology. We're looking for key players to join us as we scale our impact and build the Xensam team together. We take our culture seriously and strive to maintain the excellence, energy & enthusiasm that flows through the organization today.We look...

  • QA Specialist

    6 days ago

    Stockholm, Stockholm, Sweden CAG Contactor Full time

    AnsökanOm du är en erfaren QA-specialist som vill arbeta med spännande projekt och kunder i Stockholmsområdet ska du definitivt skicka in din ansökan.Vi erbjuder en attraktiv arbetsmiljö där du kan växa och utvecklas i din karriär.Vad vi ErbjuderVi erbjuder flexibelt distansarbete som planeras i samråd med våra kunder, samt flertalet attraktiva...

  • Senior Quality Assurance Manager

    3 days ago

    Stockholm, Stockholm, Sweden SallyQ AB Full time

    CareDx, a leading precision medicine solutions company, is seeking a dedicated Senior QA Specialist to support their mission to build a robust quality culture and ensure product compliance. As a trusted partner in transplant care, CareDx offers innovative diagnostic solutions and services that improve outcomes for organ transplant patients.About the RoleThe...

  • Cloud QA Specialist

    7 days ago

    Stockholm, Stockholm, Sweden Nordea Bank Norge ASA Full time

    About This OpportunityThis is an exciting opportunity to join our Common Data Warehousing Technology QA team as a Test Manager. As a key member of our team, you will be responsible for planning and running QA and test management for both functional and non-functional testing.Key Responsibilities:Plan and run QA and test management for both functional and...

  • Regulatory Affairs Expert

    5 days ago

    Stockholm, Stockholm, Sweden TN Sweden Full time

    RaySearch is a leading developer of innovative software solutions for cancer care. Our QA/RA team is responsible for ensuring the quality and safety of our medical devices, from development to delivery. We work closely with regulatory authorities to ensure compliance with relevant regulations and guidelines.We are seeking a highly skilled Regulatory Affairs...

  • Quality Assurance Professional

    5 days ago

    Stockholm, Stockholm, Sweden TN Sweden Full time

    We are seeking a highly motivated and experienced Quality Assurance Professional to join our QA/RA team at RaySearch. The successful candidate will be responsible for managing the project for transitioning our QMS from one digital platform to another, managing the CAPA process, and coaching the organization regarding management of individual CAPAs.The ideal...

  • QA Specialis för Företagsuppdrag

    2 days ago

    Stockholm, Stockholm, Sweden Academic Resource AB Full time

    Om JobbetVi letar efter en kunnig och erfaren QA Specialist som vill arbeta med företagsuppdrag i Stockholm. Som granskare på Academic Resource AB kommer du att ha ett viktigt ansvar i att säkerställa kvaliteten på läkemedel.

  • Ledare för Kvalitet och Regulatoriska Frågor

    7 days ago

    Stockholm, Stockholm, Sweden Moveup Consulting AB Full time

    För att fortsätta vår resa mot att förbättra cancervården behöver vi en erfaren QA/RA Manager som kan leda vårt team och säkerställa kvalitet och regulatorisk efterlevnad i våra produkter.Rollen innefattar:Teknisk dokumentation och kvalitetsledningssystem.Produktregistrering på nya marknader.Kvalitetskontroll, CAPA och...

  • Kvalitetsansvarig inom Medicinteknik

    7 days ago

    Stockholm, Stockholm, Sweden Moveup Consulting AB Full time

    Vill du vara med och skapa en bättre framtid för cancerpatienter? Vi söker en kompetent QA/RA Manager som kan leda vårt team och säkerställa kvalitet och regulatorisk efterlevnad i våra produkter.Tjänsten omfattar:Vidmakthålla teknisk dokumentation och kvalitetsledningssystem.Produtktregistrering på nya marknader.Kvalitetskontroll, CAPA och...

  • Medicinteknisk Qualitetschef

    7 days ago

    Stockholm, Stockholm, Sweden Moveup Consulting AB Full time

    För att driva vår tillväxtresa inom cancervården behöver vi en erfaren QA/RA Manager som kan säkerställa kvalitet och regulatorisk efterlevnad i våra produkter.RollenVidmakthålla teknisk dokumentation och kvalitetsledningssystem enligt ISO 13485.Ansvara för produktregistrering på nya marknader och expandera vår globala räckvidd.Säkerställa...

  • Technical Quality Specialist

    2 days ago

    Stockholm, Stockholm, Sweden TN Sweden Full time

    We're a company that values technical excellence and is committed to delivering high-quality customer experiences.Our focus is on accelerating our test automation efforts to ensure seamless customer experiences.We're looking for a Technical Quality Specialist to join our team in Stockholm, Sweden.This role involves working closely with cross-functional...

  • Software Quality Specialist

    7 days ago

    Stockholm, Stockholm, Sweden Xensam Ltd. Full time

    Xensam Ltd. is the leading provider of AI-powered Software Asset Management technology. We are looking for key players to join us as we scale our impact and build the Xensam team together.We take our culture seriously and strive to maintain the excellence, energy & enthusiasm that flows through the organization today. Our team values experience, but also...

  • GxP Specialist Lead

    2 days ago

    Stockholm, Stockholm, Sweden Recipharm Full time

    About the CompanyRPH Pharmaceuticals is a virtual organisation focusing on Intellectual property, with staff across 7 countries and a wholly owned subsidiary RPH Pharma Ltd (RPPL).We are currently integrating a new quality system and are looking for a QA Specialist to support this integration process on a 6 months fixed term contract.About the RoleThe QA...

  • Manufacturing Quality Specialist

    6 days ago

    Stockholm, Stockholm, Sweden Nordberg Medical Full time

    Nordberg Medical is seeking a highly skilled Manufacturing Quality Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for working with production teams to enhance processes, facilitate batch releases, and manage deviations and CAPA to ensure compliance and continuous improvement within the QA field.Key...

  • Cloud Infrastructure Specialist

    7 days ago

    Stockholm, Stockholm, Sweden Safemind AB Full time

    eBerry is a leading tech company within Strawberry that's revolutionizing the hotel industry. We're looking for a Cloud Infrastructure Specialist to join our Omni team and help build a scalable and secure platform.The Senior Software Developer will be responsible for designing, developing, deploying, and maintaining services for the Omni...

  • Test Automation Specialist

    5 days ago

    Stockholm, Stockholm, Sweden Starbreeze Full time

    About the Role: We are seeking a talented Test Automation Specialist to join our Central Tech team in Stockholm. As a Test Automation Specialist, you will be responsible for designing, implementing, and maintaining automated test systems for our in-development projects.The Central Tech team at Starbreeze is responsible for delivering software and software...