Quality Assurance Officer/Manager

General Information

Role Title Quality Assurance Officer/Manager
Vacancy Owner/Will report to Director Operations
Full-time/part-time 60% – 100%
Desired Starting Date 2021 Sep 1

Job Description

At Sirius we improve care for cancer patients through our effective, affordable localization system, enabling the precise and efficient surgical removal of tumors. Our ambition is to offer a solution that provides value across the patient-care pathway. Our aim is that our system becomes accessible to every breast cancer center looking for a better alternative.

Our Sirius Pintuition system has MDD-CE mark since 2020 and US FDA-510(k) clearance since early 2021. We are running initial commercial business in EU and are preparing US sales. In parallel, we develop new innovative features for our products, requiring MDR transition of our dossiers and keeping our regulatory dossiers for FDA up to date.

To support the growth of our activities, we seek support from an experienced quality assurance officer with the potential to grow towards quality assurance manager position. You will join a small multi-disciplinary team of medical device experts (technology, clinical, quality, business, operational) in which you assure compliance with our ISO 13485:2016 certified and 21 CFR part 820 compliant QMS.

  • You manage our quality system processes (a.o. non-conformities, complaints, CAPA’s, and changes)
  • You take ownership of document and record management (DHF/DMR/DHR)
  • You prepare production and release documentation
  • You perform supplier evaluation activities
  • You contribute to product development with quality reviews, design reviews, and risk assessments
  • You support MDD to MDR transition of our technical files and maintenance of our 510(k) dossiers
  • You have higher professional education level in an engineering discipline
  • Multi-year experience in a quality role in the medical devices sector
  •  Working knowledge of ISO 13485:2016 and 21 CFR part 820
  • You have experience with performing audits
  • You pride yourself in your attention to detail. You stay focused where others lose it.
  • You are pragmatic when needed and work with the team to find creative solutions
  • You are accurate and don’t like open ends; you’re a finisher
  • You have strong communicative skills
  • You are a high-energy, self-motivated, pro-active individual able to work in a diverse team within a dynamic startup company
  • You are fluent in English and preferably Dutch. Mastering of other languages is appreciated.

Sirius Offers

Company and environment
Sirius Medical is a start-up, founded as a spin-out from the Netherlands Cancer Institute and Twente University in 2017. The company has been highly successful by developing and launching innovative medical technology that help surgeons across the globe in a very short period of time.

Sirius is funded by external capital and has a team of highly dedicated people with entrepreneurial mindset working on its products.

We offer a great team to work with, and on the High Tech Campus we enjoy an environment that enable us creating products that matter in the lives of people. You will have the freedom to steer your own work and the responsibility to make it happen.

We will pay a competitive salary.

About us:

With its roots in the Netherlands Cancer Institute, Sirius Medical was born to make things better. The Sirius Pintuition system was developed by and for surgeons addressing a clear clinical need with a solution that simply makes sense. The Sirius Pintuition system is CE marked and received FDA clearance and is currently commercially available in Western Europe. Our mission is to improve care for cancer patients by delivering unsurpassed, yet affordable solutions that enable precise and efficient surgical removal of tumors.


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