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Quality Engineer - Your growing role is key in channelling our quality thinking into documentation.

Together with our Quality and Regulatory Manager, as a Quality engineer you will play a pivotal role in bringing our medical devices to market. You are eager to understand the worlds of technical team, clinicians, and management and you collaborate with them on a daily basis. You want to be part of the team creating a submission file to authorities and understand how this impacts our development process.

We’re a startup growing to scaleup, so you’re going to have a big impact. Our ambition is that you will grow in your role to a Quality Assurance reviewer and become directly involved in development, approval and maintenance of our innovative products. In short, we’re looking for someone with the ambition of a changemaker, understanding business processes and bringing structure in our growing company.


At Haermonics we are dedicated to make post operative care safer for cardiac patients by implementing innovative pericardial flushing therapies and monitoring solutions.

Your responsibilities:

In general, you’re the champion of Quality and Regulatory matters. More specifically you are expected to:

  • Support development and maintenance of our Quality Management System procedures
  • Play a vital role in application of design controls for developing new products. You will review documents and procedures and ensure structured way of working.
  • Serve as point of contact in the area of medical device regulatory requirements
  • Serve as Haermonics’ Quality representative and support collaboration with and management of our strategic suppliers
  • Support Risk Management Activities
  • Support execution of Quality Management Procedures
  • Maintain Quality Metrics
  • Support Quality Planning through Quality Management System, and development and maintenance of our products
  • Drive of completion of quality and regulatory deliverables
  • Support auditing activities

What you bring to the team:

  • Bachelor degree in engineering or equivalent
  • Experience within regulated industry (1 to 3 years of experience within Quality or Regulatory Affairs function in Medical Device is a plus).
  • Basic understanding and experience with managing projects (plan, do, check, act, prioritize)
  • Experience in data handling and statistical methodologies
  • Proficiency in use of MS Office Package (Word, Excel, PowerPoint, Outlook)
  • Attention to detail
  • Ability to communicate effectively (oral and written communication skills)
  • Affinity with working in a can-do startup setting (eager, lean and compliant)
  • Ability to work independently and self motivated
  • You are a team player and are eager to collaborate cross functionally

What we offer:

Our goal is to save 10,000 lives by 2030. So we’re looking to build a dedicated team that we can count on, so that others can count on us. This is a great development opportunity in Quality Engineering field including working knowledge of relevant for Medical Device Regulations and application of standards. Besides a driven purpose, joining the Haermonics team will give you:

  • A competitive salary
  • 28 Days of leave
  • Colleagues who are the best and brightest in their field
  • Remaining “the best and brightest” requires ongoing dedication; we contribute to free training and coaching
  • A young, dynamic, international, high-tech scale-up environment, where you will collaborate daily with top-level medical device suppliers and partners
  • Hybrid work-from-home options and flexible work schedule
  • A share package (because our success is your success and we’re looking for long-term committers)