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

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