Quality Manager QA/RA · Helsinki ·

2 days ago


Helsinki, Uusimaa, Finland Topconhealth Full time

Are you passionate about encouraging a culture of quality and ensuring that products meet high standards? Do you dream of working with products that truly improve the quality of life for people across the globe? Great, because we have a job opening for you As a Quality Manager, you'll have an impact on ensuring the delivery of high-quality software products focused on customer needs.

What kind of work is this?

We are looking for a skilled and detail-oriented individual to join our QARA team to ensure efficient and compliant processes are followed, and high-quality product delivery. If you have proven experience, especially with ISO 13485 and EU MDR requirements, along with implementing those into practice and you excel at what you do, we welcome you to join our dynamic and motivated team.

In this role, you'll actively collaborate across different departments within the Company and support their activities to ensure compliance with applicable regulations, and standards.

This role is based in our Helsinki office with the option for hybrid work. Please note that we do not provide relocation services for this position.

Your main responsibilities will be:

  • Act as Internal Auditor - ISO 13485:2016
  • Act as CAPA Leader; guide cross-functional teams through the process ensuring timely completion of CAPA.
  • Take part in evaluating suppliers, subcontractors, external services, etc. on quality issues.
  • Provide training on applicable QMS processes
  • Preparing and reviewing relevant documents e.g. in the Technical File
  • Participate in audits by external parties and resolve issues
  • Review labeling to determine compliance with labeling requirements.
  • Support Post-Market Surveillance (PMS) activities

What do you expect from me?

We're looking for a skilled, quality-minded person, who can embed quality and compliance best practices across different activities. Below are the key qualifications and experiences that will help you succeed in this role:

  • Solid understanding and proven working experience with ISO 13485, EU MDR, and 21 CFR §820.
  • Internal auditing certification or proven experience in internal auditing
  • Hands-on experience in CAPA process
  • Knowledge of IEC 62304 and ISO/IEC 27001 is seen as an advantage
  • Strong written and verbal communication skills
  • Excellent collaboration skills
  • Well-organized and able to work independently
  • Fluent written and spoken English skills

If this role sounds like a great fit for you, we'd love to hear from you Send us your application (including your salary request) along with your CV by March 31st, 2025. Please apply as soon as possible; the position will be filled once a suitable candidate is found.

We review applications on a rolling basis and strive to keep you informed about your progress throughout the process. If you'd like to learn more about the position, feel free to contact our Head of QA/RA Anita Jansen at 040564 9883.

#J-18808-Ljbffr
  • Quality Manager

    2 days ago


    Helsinki, Uusimaa, Finland Topconhealth Full time

    Are you passionate about encouraging a culture of quality and ensuring that products meet high standards? Do you dream of working with products that truly improve the quality of life for people across the globe? Great, because we have a job opening for you As a Quality Manager, you'll have an impact on ensuring the delivery of high-quality software products...


  • Helsinki, Uusimaa, Finland Supercell Full time

    We are looking for a skilled Senior QA Engineer to join our Helsinki-based team. As a key member of our quality assurance team, you will be responsible for designing and implementing comprehensive testing strategies to ensure the highest level of game quality and player satisfaction.Key Responsibilities:Develop Testing Strategies: Collaborate with...

  • QA Technical Lead

    4 days ago


    Helsinki, Uusimaa, Finland Moventas Wind Ltd Full time

    We are looking for a QA Technical Lead to join our team at Moventas Wind Ltd. In this role, you will be responsible for leading our QA team and ensuring the quality and reliability of our digital products.Job DescriptionYou will provide technical leadership and guidance to our QA team, overseeing the development and implementation of automated testing...

  • Quality Manager

    2 days ago


    Helsinki, Uusimaa, Finland Topcon Healthcare Solutions Oy Full time

    Are you passionate about encouraging a culture of quality and ensuring that products meet high standards? Do you dream of working with products that truly improve the quality of life for people across the globe? Great, because we have a job opening for you As a Quality Manager, you'll have an impact on ensuring the delivery of high-quality software products...

  • Game Quality Expert

    2 hours ago


    Helsinki, Uusimaa, Finland Supercell Full time

    Supercell is seeking a seasoned Senior QA Professional to join our Helsinki-based team. As a key member of our quality assurance team, you will be responsible for ensuring the highest level of game quality and player satisfaction.Key Responsibilities:Design and Execute Testing Plans: Develop and implement comprehensive testing strategies to validate game...

  • Quality Manager

    2 days ago


    Helsinki, Uusimaa, Finland Topcon Healthcare Solutions Full time

    Are you passionate about encouraging a culture of quality and ensuring that products meet high standards? Do you dream of working with products that truly improve the quality of life for people across the globe? Great, because we have a job opening for you As a Quality Manager, you'll have an impact on ensuring the delivery of high-quality software products...


  • Helsinki, Uusimaa, Finland CVX Ventures Full time

    Job Title: Helsinki Investment ManagerWe are seeking an accomplished Helsinki Investment Manager to oversee our investments in Helsinki, with a keen eye for identifying and analyzing business plans and markets.Main ResponsibilitiesFoster a continuous high-quality deal flow by identifying and analyzing business plans and markets.Evaluate companies, markets,...


  • Helsinki, Uusimaa, Finland CVX Ventures Full time

    **About CVX Ventures**C VX Ventures is a global investment team focused on identifying and investing in high-growth Nordic companies. We are seeking an exceptional Helsinki Investment Manager to join our team and contribute to our success.The ideal candidate will have a passion for analyzing and investing in companies, as well as a strong network of contacts...


  • Helsinki, Uusimaa, Finland Nordea Bank Norge ASA Full time

    About this opportunityWelcome to the international team of test automation enthusiasts. We add value by increasing production stability and cost efficiency while creating and deploying new solutions to our customers.As a Senior Manual Test Engineer, you'll play a valuable role in increasing quality of delivering solutions focusing on automation. Review...

  • QA Tester

    2 hours ago


    Helsinki, Uusimaa, Finland Supercell Full time

    At Supercell, we're passionate about creating engaging and immersive gaming experiences. As a Senior Game Tester, you'll play a critical role in ensuring the quality and fun factor of our games.Main Responsibilities:Test Game Functionality: Verify game features, mechanics, and user interface to ensure they meet our high-quality standards.Identify and Report...


  • Helsinki, Uusimaa, Finland Four FM AB Full time

    At Four FM, we provide premium solutions within Facility Management. As a fast-growing company, we prioritize close collaboration between our personnel on site and management, providing opportunities to exchange experiences and knowledge.We are seeking a Facility Coordinator to join our team in Helsinki. In this role, you will deliver facility management...

  • Quality Control

    2 days ago


    Helsinki, Uusimaa, Finland Nanoform Full time

    About NanoformNanoform is an innovative drug particle engineering and nanotechnology company listed on the Premier-segment of Nasdaq First North Growth Market in Helsinki and Stockholm. Nanoform works together with pharma and biotech partners globally to reduce attrition in clinical trials and enhance their molecules' formulation performance through its...


  • Helsinki, Uusimaa, Finland ReOrbit Full time

    We are looking for a dynamic and experienced Product Assurance professional to join our team at our HQ in Helsinki. This is a pivotal role as you will oversee the implementation of product assurance requirements throughout the entire project lifecycle for all projects across the company.This is our first dedicated PA position, so it is vital for us to find...


  • Helsinki, Uusimaa, Finland RB Global Inc. Full time

    **Manager, Software Engineering in Helsinki, Uusimaa, Finland (# 2908)**** Job Description****About The Team**Our Technology teams work collaboratively from different locations across the world on multiple eCommerce sites, mobile applications, and automated online auctions. We encourage and celebrate technical innovation and work with some of the industry's...


  • Helsinki, Uusimaa, Finland Supercell Full time

    Helsinki – onsite – full-time, permanentSenior Game Tester, New Game: mo.coOur game teams are focused on building great games that will be played by many players for many years. Every part of the game, from design to code, needs to be top quality in order to reach this goal. Our developers do everything they can to deliver, but we believe it's essential...


  • Helsinki, Uusimaa, Finland Supercell Full time

    Helsinki-based Supercell, a global leader in the mobile gaming industry, seeks an experienced Game Quality Expert to join our team.Main Responsibilities:Quality Improvement: Collaborate with cross-functional teams to identify and mitigate game quality issues, ensuring a seamless player experience.Testing Strategy: Develop and execute comprehensive testing...


  • Helsinki, Uusimaa, Finland Nordea Bank Norge ASA Full time

    Job OverviewWe are seeking a highly skilled Senior Manual Test Engineer to join our Cards Technology team. As a Senior Test Engineer, you will play a critical role in ensuring the quality and reliability of our payment solutions.Key ResponsibilitiesDesign and implement E2E test scenarios and casesExecute tests and report results, including defectsProactively...


  • Helsinki, Uusimaa, Finland Unilever Full time

    Unilever's Value Channel Customer Business Development team in Helsinki is searching for a talented Customer Development Manager to drive commercial growth and competitiveness.As a Customer Development Manager, you will develop and execute commercial strategies and customer business plans, working closely with customer teams and category managers.Your...

  • Civils Managers

    4 hours ago


    Helsinki, Uusimaa, Finland Winthrop Technologies Full time

    SummaryWinthrop Technologies is a dedicated data centre delivery partner providing turnkey solutions to our clients, headquartered in Dublin and delivering throughout Europe.Winthrop specialises in providing turnkey data centre solutions, providing services from design, through to construction across the full range of civil, structural, architectural,...


  • Helsinki, Uusimaa, Finland Unilever Full time

    Are you a results-driven Account Management Lead looking for a new challenge? We are seeking an experienced professional to join our Value Channel Customer Business Development team in Helsinki.In this role, you will be responsible for leading customer relationships, developing and executing commercial strategies and business plans, and driving positive...