Step into a senior quality role where your expertise will drive compliance, continuous improvement plus meaningful impact across healthcare innovation.
What is offeredReady to grow your career and make real impact? Join MindCapture!
We offer competitive salaries, a full benefits package with meal vouchers, eco vouchers, DKV health insurance, group insurance, net expense allowance plus a company car. You also get the opportunity to shape your future through personalised training plus development.
At MindCapture, you choose what you love, build on your strengths, and make a difference where it matters most.
You will work as a MindCapture consultant or freelancer for an international market leader in the healthcare industry.
Job Description:Maintain plus continuously improve the Quality Management System in line with ISO 13485:2016 plus MDR requirementsSupport internal plus external quality audits including Notified Body inspections plus supplier auditsEnsure Quality Management System documentation aligns with relevant MDR requirementsOversee CAPA, non conformance plus change control processes to ensure timely resolution plus complianceEnsure product plus process compliance with EU MDR 2017/745 including technical documentation, post market surveillance plus vigilanceCollaborate with Regulatory Affairs to support submissions, renewals plus responses to external bodiesMonitor regulatory changes plus implement updates to quality systems plus product documentationSupport complaint handling, root cause analysis plus trending for continuous improvement
Requirements:Bachelor's or Master's degree in engineering, life sciences or quality managementMinimum 5 years of experience in QA roles within the medical device industryStrong expertise in ISO 13485:2016, EU MDR 2017/745 plus applicable standards such as ISO 14971 plus IEC 62304Experience with Class IIa, Class IIb or Class III devices plus Notified Body interactionsStrong leadership, project management plus communication skillsProficiency in Quality Management System software plus document control systems3-4 days on-site presence is required (North of Antwerp)
Are you ready to make a real difference in healthcare?Join our dynamic team and help drive innovation in medical devices.
Apply now and let's make an impact together!Want to learn more? Discover all opportunities at www.mindcapture.com.
If MindCapture sees a potential fit, we'll get in touch as soon as possible.If you don't hear from us within two weeks, it simply means that this particular position wasn't the right match. In that case, we'll gladly keep your profile in mind for future roles that could suit you better.