Amsterdam, North Holland, Netherlands · On-site
Your mission Would you like to safeguard quality and regulatory compliance at the forefront of cancer diagnostics? As QA/RA Lead you will be the accountable owner of quality and regulatory compliance across the Business …
Skills: Quality Assurance, Regulatory Affairs, ISO 13485, ISO 15189, ISO 27001
Amsterdam, North Holland, Netherlands · On-site
$4k–$6k/mo
Your mission Would you like to contribute to Hartwig’s mission to improve care for patients with cancer? At Hartwig Medical Foundation (Hartwig), we are dedicated to improving care for patients with cancer through high-q…
Skills: Validation Workflow Development, Regulatory Compliance, Quality Management Systems, ISO 17025, ISO 15189
Amsterdam, North Holland, Netherlands · On-site
Your mission Wil jij bijdragen aan de missie van Hartwig Medical Foundation om de zorg voor patiënten met kanker te verbeteren? Hartwig werkt intensief samen met ziekenhuizen, onderzoeksinstellingen en technologiepartner…
Skills: Contract Law, Corporate Governance, Regulatory Compliance, Data Law, GDPR
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You will lead a cross-functional quality team to manage the integrated quality and regulatory framework across international business units. This includes overseeing QMS compliance, regulatory strategy for medical software, and fostering a culture of quality throughout the organization.
Candidates must hold a Bachelor's or Master's degree in a relevant scientific or engineering field and possess over 10 years of experience in QA/RA within the medical device or IVD industry. Strong expertise in ISO standards, Notified Body audits, and hands-on leadership in a regulated environment is required.
You will own and continuously strengthen our integrated quality and regulatory framework, while staying closely involved in the day-to-day work of your team:
You are an experienced QA/RA professional who combines regulatory depth with hands-on leadership:
At Hartwig Medical Foundation, every day we work with one clear goal: to ensure that every patient with cancer receives the treatment best suited to their unique situation. We achieve this by developing comprehensive DNA testing that helps hospitals analyze tumors with precision and supports clinicians in making informed treatment decisions. At the same time, we are building a rich knowledge base on patients, tumors, and treatment outcomes, so that the care delivered today contributes to the breakthroughs of tomorrow.
Our organization is driven by both data and people. We collaborate closely with hospitals, researchers, and partners across the Netherlands to lower the barriers to personalized cancer care. Join our multidisciplinary team of experts — including medical professionals, analysts, bioinformaticians, and software developers — and help us make a real impact on patient care.
Learn more about our organization at hartwigmedicalfoundation.nl.
Location: Science Park 408, 1098 XH, Amsterdam, Netherlands
We do not consider collaborations with agencies or freelancers for this position.
Improved care for cancer patients driven by data
Hartwig Medical Foundation is a non-profit organization with the mission to improve cancer patient care. We support treatment decisions through a combination of innovative software, clinical data analyses, and molecular diagnostics. This enables patients to timely receive the right treatment, while generating valuable data that supports research and the continuous improvement of care. What do our colleagues think of their work at Hartwig? Some statements: “I work here because I want to help improve society.” “It is nice to work in a team of very experienced developers. Daily, we work with our partners in Australia, Canada and Spain.” “We work closely with scientists.” “The atmosphere is informal.” “The pace is fast, we have high standards. We are focused on the content and avoid unnecessary processes as much as possible. We are very flexible. If it turns out that a different way of working is better, we can quickly adapt.” “The balance between pace and relaxation is important.” “My ideas are appreciated.”
Offices: Science Park 408, Amsterdam, 1098XH, NL · Science Park 404, Amsterdam, 1098 XH, NL
Improved care for cancer patients driven by data
Hartwig Medical Foundation is a non-profit organization with the mission to improve cancer patient care. We support treatment decisions through a combination of innovative software, clinical data analyses, and molecular diagnostics. This enables patients to timely receive the right treatment, while generating valuable data that supports research and the continuous improvement of care. What do our colleagues think of their work at Hartwig? Some statements: “I work here because I want to help improve society.” “It is nice to work in a team of very experienced developers. Daily, we work with our partners in Australia, Canada and Spain.” “We work closely with scientists.” “The atmosphere is informal.” “The pace is fast, we have high standards. We are focused on the content and avoid unnecessary processes as much as possible. We are very flexible. If it turns out that a different way of working is better, we can quickly adapt.” “The balance between pace and relaxation is important.” “My ideas are appreciated.”
Offices: Science Park 408, Amsterdam, 1098XH, NL · Science Park 404, Amsterdam, 1098 XH, NL
