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Quality Manager

4 weeks 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 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

Why should I apply for a job at Topcon Healthcare Solutions?

You can come here as you are. We appreciate all personality types and truly believe that a good team consists of a wide range of different, unique characters. Our team of over 120 professionals in Finland has a relaxed atmosphere, and we think that a bit of humour makes work a lot easier.

You'll have the chance to do meaningful work - shaping the future with innovative technology and creating solutions that make a difference. With a global work environment, you'll connect with colleagues and ideas from around the world, bringing fresh perspectives and opportunities for development.

We equip you with excellent tools, inspiring spaces, and a team that supports you every step of the way. On top of that, you'll enjoy benefits like a lunch allowance, sports, massage and culture vouchers, and leisure-time insurance, and an education benefit to support your professional development.

If this sounds like the kind of workplace you've been looking for, we'd love to hear from you.

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

I'm interested to hear more What should I do next?

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, on March 18th, 2025, from 13:00 to 14:00, Finnish time.

What does the recruitment process look like?

We want to ensure the recruitment process is clear and transparent for you.

Initial Interviews:

We'll begin with initial discussions via Teams. This is a chance for us to get to know each other better and for you to ask any questions you might have.

In-Depth Discussions:

If selected to move forward, you'll participate in more detailed discussions involving both technical experts and HR. We'll dive deeper into the role, your expertise, and how we can collaborate.

Final Interviews:

The final stage will be a one-on-one discussion, typically with senior decision-makers. After this, we'll verify references and move to contract negotiations.

We'll provide detailed updates as the process progresses and inform you of any changes to the timeline or structure. Our aim is to make the experience as smooth and clear as possible.

Who is Topcon?

Topcon Healthcare Solutions is part of Topcon Corporation. Topcon Corporation is focused on developing solutions to solve societal challenges in the mega domains of healthcare, agriculture, and infrastructure. In healthcare, these challenges include increasing eye disease, rising medical costs, physician shortages, and unequal access to healthcare. By investing in value-driven innovations, Topcon Corporation works to help people enjoy good health and a better quality of life.

We are a leading provider of digital healthcare solutions whose vision is to improve access and quality of healthcare while decreasing the cost of care. To achieve this vision, we created Healthcare from the Eye, the strategy of applying AI models to imaging data from the eye to facilitate earlier detection and better management of disease. Healthcare from the Eye is powered by Harmony, a cloud-based, vendor-inclusive digital health information platform enabling a connected care ecosystem. In addition, RDx, our remote diagnostic platform, enhances access to care by enabling eye exams to be conducted remotely, allowing doctors to connect to the point of care from virtually anywhere. Together, Harmony, RDx and the AI models empower healthcare professionals to deliver more connected, accessible, and efficient care.

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