Senior Quality Assurance Specialist

11 hours ago


Stockholm, Stockholm, Sweden Capgemini Full time

We are seeking a Senior Quality Assurance Specialist to join our Compliance, Quality and Regulatory team (CQR) for an exciting assignment within medical device development. The primary role of this position is to be responsible for timely planning and proper execution of test engineering in medical device development projects, based on identified and agreed needs to fulfill objectives at the project level.

Key Responsibilities Include:

  1. Act as Functional Test Lead on device projects
  2. Execute Test Engineering Work Packages
  3. Plan, execute, review and report on testing
  4. Drive strategic improvement opportunities, establish best practices, and share knowledge
  5. Act as process or subject matter expert
  6. Act as strategic test partner to client's device project teams

Main Job Tasks

As Senior Quality Assurance Specialist at Capgemini, you will:

  1. Act as functional test lead on device projects and represent Test Engineering and Test Execution teams in projects throughout the development process
  2. Coordinate all deliverables with functional method validation leads and lab technicians and be accountable for project investigations
  3. Execute test engineering packages and participate, contribute and provide input to specifications, project plans, protocols, and reports
  4. Identify and drive improvement opportunities, complex solving, and create new guidance
  5. Ensure training for the test team in expertise areas
  6. Lead and facilitate strategic test-related project decisions

Requirements and Qualifications

Capgemini believes that you have a degree in Mechanical/Biomedical Engineering or a related engineering discipline, with 2-5 years of experience in test engineering within medical device development, including the following aspects:

  1. Tests and measurements
  2. Verification of requirements
  3. Data analysis & statistics
  4. Test standards and regulations
  5. Requirements engineering
  6. Medical device design control
  7. Project management
  8. Navigating a GMP-regulated environment
  9. cLEAN
  10. Business understanding and end-to-end mindset
  11. Establishing and enabling strategy
  12. Defining and driving process improvements or digitalization

Excellent understanding of medical device regulations and standards, such as 21CFR820, ISO13485, and ISO17025, and proven track record of successfully managing testing within medical device development projects. Strong communication skills and leadership abilities, effectively collaborate with cross-functional teams, stakeholders, and external partners.



  • Stockholm, Stockholm, Sweden SQA Services Full time

    SQA Services is seeking a highly skilled Quality Assurance Specialist to join our global quality auditing team. As a Senior Quality Auditor, you will play a critical role in assuring quality in the supply chains of our clients in life sciences.This position offers an exciting opportunity to work closely with SQA's operations center to coordinate, prepare,...


  • Stockholm, Stockholm, Sweden VIPAS AB Full time

    At VIPAS AB, we are seeking a highly skilled Senior Quality Assurance Specialist to join our team and play a key role in ensuring the quality of our B2B self-service solutions.About UsWe are an IT consulting company that delivers tailored solutions using cutting-edge technologies like Java and Python. Our team is well-versed in software development, DevOps,...


  • Stockholm, Stockholm, Sweden OHB Sweden AB Full time

    OHB Sweden AB is a leading provider of satellite systems and space solutions. We specialize in developing cutting-edge technology for Earth observation, telecommunications, and scientific research.We are seeking an experienced Quality Assurance Specialist to join our team in Kista. As a key member of the Quality & Product Assurance team, you will be...


  • Stockholm, Stockholm, Sweden Igbaffiliate Full time

    Igbaffiliate is looking for a skilled Quality Assurance Specialist to join our team. As a Quality Assurance Specialist, you will be responsible for ensuring the quality and reliability of our web applications.Responsibilities:Verify implemented functionality and tasksCreate and maintain test documentation (Test Cases, Bug Reports, Checklists)Communicate with...


  • Stockholm, Stockholm, Sweden TN Sweden Full time

    Haleon is a world-leading consumer health company improving everyday health for billions of people.This is an exciting time to join us and help shape the future. It's an opportunity to be part of something specialAbout the roleThe Senior Quality Assurance Specialist will ensure compliance with our standards, GDP, and local regulatory requirements.Key...


  • Stockholm, Stockholm, Sweden TN Sweden Full time

    Job DetailsWe are seeking a Senior Quality Assurance Engineer to join our team at TN Sweden. As a Senior Quality Assurance Engineer, you will be responsible for ensuring that delivered systems meet specified verification objectives by leading the verification and validation process.About the RoleThe ideal candidate will have a degree or passion in...


  • Stockholm, Stockholm, Sweden Sobi - Swedish Orphan Biovitrum AB (publ) Full time

    Job OverviewSobi - Swedish Orphan Biovitrum AB (publ) is a global company dedicated to transforming the lives of people living with rare diseases. We are seeking a highly skilled Quality Assurance Specialist to join our team.This role will play a pivotal part in ensuring eCompliance and driving digital quality decisions through effective GxP system lifecycle...


  • Stockholm, Stockholm, Sweden Recipharm AB Full time

    Reporting to the Quality Director, we are seeking a talented Quality Assurance Specialist to support the management and oversight of QMS processes in our virtual organisation, Recipharm AB. This is a hybrid role with possibilities to work from home as well as from our office in Sweden (Stockholm HQ) or the UK (office located in Cheadle).Main Tasks &...


  • Stockholm, Stockholm, Sweden Edmond Pharma S.R.L. Full time

    Job Description:RPH Pharmaceuticals is seeking a Quality Assurance Specialist to support the integration of our new quality system. As a key member of our QA team, you will be responsible for managing and maintaining our eQMS, ensuring compliance with Global Quality requirements.Main Responsibilities:Manage GxP training and perform SOP training.Track KPIs...


  • Stockholm, Stockholm, Sweden Sobi group Full time

    Transforming Lives through QualityAbout the RoleWe are seeking a highly skilled Quality Assurance (QA) Specialist to join our team as a QA Analytical Specialist Lead. In this pivotal role, you will be responsible for ensuring the quality of analytical activities and stability studies, while also overseeing the implementation of Good Manufacturing Practice...


  • Stockholm, Stockholm, Sweden Atlas Copco Holding GmbH Full time

    We are looking for a Quality Assurance Specialist to support product quality across the globe. As part of our Engineering department, you will work closely with cross-functional teams to ensure the highest quality of our products.Our solutions are designed to improve efficiency, quality, safety, speed, usability, ergonomics, and environmental performance....


  • Stockholm, Stockholm, Sweden TN Sweden Full time

    Social network you want to login/join with:We're Haleon, a world-leading consumer health company. Our goal is improving everyday health for billions of people. We do this by growing and innovating our global portfolio of category-leading brands.This is an exciting time to join us and help shape the future. It's an opportunity to be part of something...


  • Stockholm, Stockholm, Sweden TN Sweden Full time

    We are seeking a skilled Software Quality Assurance Specialist to join our team at TN Sweden.Job Description:The successful candidate will be responsible for managing and coordinating deviations in the SAP system, driving root cause analyses, and compiling quality statistics to present to management.Coordinate and manage deviations in the SAP system,...


  • Stockholm, Stockholm, Sweden Rasulson Consulting AB Full time

    Rasulson Consulting AB is a leading provider of IT recruitment services in the Nordic region.About Our ProjectWe are currently working on a strategic IT and business initiative designed to transform our IT landscape in support of vital business changes for Consumer Sales in Finland.The project aims to replace the existing customer information system,...


  • Stockholm, Stockholm, Sweden TN Sweden Full time

    At Vipas AB, we are committed to delivering high-quality software solutions that meet the needs of our customers.Role OverviewWe are seeking a highly skilled Senior Quality Assurance Specialist to join our team. As a key member of our development team, you will be responsible for designing, developing, and executing test automation scripts using Python.The...


  • Stockholm, Stockholm, Sweden teenage engineering Full time

    As a leader in the industry, Teenage Engineering is constantly pushing the boundaries of innovation and excellence. To support this mission, we're seeking an experienced Senior Quality Manager to lead our quality efforts.You'll be responsible for overseeing the development and implementation of quality assurance policies and procedures, ensuring that all...


  • Stockholm, Stockholm, Sweden TN Sweden Full time

    Farm Heroes Saga is now seeking a highly skilled Senior Test Automation Engineer to join our team in Stockholm, Sweden. As a key member of our quality assurance department, you'll be responsible for designing and implementing end-to-end test automation strategies for our mobile games.Your primary focus will be on developing and maintaining automation...


  • Stockholm, Stockholm, Sweden Hitachi Vantara Corporation Full time

    About the Job:We're looking for a Quality Assurance Specialist to join our team as a QA Automation Engineer. This onsite position in Stockholm, Sweden offers the opportunity to work in a dynamic environment combining automation expertise with hands-on hardware testing.Responsibilities:Design and implement QA processes and automation frameworks focusing on...


  • Stockholm, Stockholm, Sweden TN Sweden Full time

    TN Sweden is looking for a Quality Assurance Expert to join our team and help us ensure the highest level of quality in our payment systems. In this role, you will be responsible for designing and implementing quality assurance processes and procedures to ensure that our payment systems meet the required standards.You will work closely with the development...


  • Stockholm, Stockholm, Sweden TN Sweden Full time

    We are seeking a skilled Test and Quality Assurance Specialist, Global Dynamics 365 to lead our testing efforts and ensure the highest level of quality for our Dynamics 365 CRM platform.Key ResponsibilitiesTest Strategy and Planning:Collaborate with business and vendor stakeholders to understand testing needs and ensure thorough test coverage.Quality...