Join MindCapture as a consultant where your process validation expertise can drive quality, compliance plus operational excellence in healthcare.
What is offered?
Ready 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:
* Support the development, execution plus follow up of process validation activities for manufacturing processes in a regulated medical device environment
* Prepare validation protocols, coordinate execution on the production floor plus ensure accurate reporting of validation results
* Evaluate process performance, identify risks plus deviations, plus propose corrective actions or process improvements where needed
* Contribute to the continued validation status of manufacturing processes plus ensure documentation remains complete plus inspection ready
* Provide hands on QA support to production teams to ensure activities are performed in compliance with internal procedures plus applicable quality standards
* Draft, review plus update work instructions plus related production documentation
* Support deviations, non conformities plus investigations related to production processes plus ensure appropriate documentation plus follow up
* Work closely with operators plus manufacturing stakeholders to strengthen quality awareness plus ensure procedures are practical plus effective
* Ensure process related documentation is aligned with ISO 13485 requirements plus internal quality system expectations
* Support the implementation plus maintenance of controlled documentation linked to production plus process changes
* Contribute to change control, CAPA plus continuous improvement activities related to process performance plus product quality
* Help ensure validation plus QA activities are performed in a structured plus compliant manner, with strong attention to traceability plus documentation quality
* Collaborate with QA, production, engineering plus other internal stakeholders to align validation activities with operational needs
* Act as a practical plus structured quality partner on process level, bridging shop floor realities with quality plus compliance requirements
* Support improvement initiatives by translating process observations into concrete quality plus validation actions
Requirements:
* Bachelor’s or Master’s degree in engineering, life sciences, biomedical sciences or a related technical field
* Minimum 3 to 5 years of experience in process validation, manufacturing quality or production QA within the medical device industry or another highly regulated environment
* Strong knowledge of ISO 13485
* Experience with process validation documentation, protocol writing, execution plus reporting
* Experience supporting QA activities in a production environment including work instructions, deviations plus change documentation
* Strong understanding of manufacturing processes plus the ability to work at process level in close collaboration with operations
* Structured, hands on plus quality minded professional with strong documentation skills
* Able to combine operational pragmatism with compliance awareness plus critical thinking
* Good communication skills plus the ability to work effectively across QA, production plus technical teams
* On site presence of 4 days per week
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!
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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.