Senior Quality Engineer
What is offered?
At MindCapture, you are not just taking on a new job; you are joining a community that values who you are and what you bring to the table.
We offer you:
- A competitive salary and a full benefits package including 32 vacation days, meal and eco vouchers, DKV health insurance, group insurance, net expense allowance, and a company car with fuel or charging card, or a mobility budget.
- Real ownership in your role where your voice matters and your input is heard.
- Personal growth support through coaching, tailored training, and clear career paths matching your ambitions.
- The chance to work on projects with purpose for leading clients, with a direct impact on a healthier and cleaner world.
- A warm and open company culture where teamwork, trust and connection are at the heart of everything we do.
- A spot in a fast-growing team where you can shape your future while helping shape ours.
Job description
We are looking for an experienced Senior Quality Engineer with a strong background in medical device quality systems and supplier quality. The role focuses on design control, documentation management and supply chain development within a regulated manufacturing environment.
Design control and documentation management
Maintain Design History Files in compliance with FDA 21 CFR Part 820, ISO 13485:2016 and MDR. Ensure completeness of quality deliverables such as risk management files, V&V protocols and reports, traceability matrices and related documentation. Facilitate effective change control processes during design and process changes.
Supplier quality and supply chain development
Support the selection, qualification and monitoring of key suppliers. Ensure supplier controls meet regulatory requirements and internal specifications. Participate in supplier audits and performance reviews to safeguard compliance.
Quality system support
Collect input for and support the preparation of management reviews. Facilitate training management processes. Assist in internal and external audits. Investigate quality events and ensure effective CAPA implementation.
Required competences & skills
- Bachelor’s degree in Science, Engineering or a related field
- 10+ years of experience in quality engineering within a manufacturing setting
- In-depth knowledge of ISO 13485, FDA 21 CFR 820 and MDR
- Familiarity with electronic QMS tools for documentation, supplier and training management
- Strong communication and cross-functional collaboration skills
- Proactive mindset with the ability to work independently
About this application
As a Senior Quality Engineer at MindCapture, you will play a pivotal role in ensuring compliance and quality excellence in medical device development and manufacturing. This position is ideal for a seasoned professional who wants to combine technical knowledge with supplier management and quality system oversight. You will contribute to safer products, stronger processes and a reliable supply chain that supports long-term success.
Job Contact
Silke – Talent & Business Manager
Silke combines a deep understanding of our clients’ needs with a sharp eye for talent. She’s here to answer your questions, provide context about the role and support you in taking the next step in your career.
How our application process works
- Apply online – Submit your application in just a few clicks.
- Personal interview – If we see a potential match, our team reaches out to get to know you better, explore your skills and ambitions and hear what you value in your next challenge.
- Client introduction – We match you with potential projects and introduce you to clients where your expertise fits best.
- Client interview & feedback – You meet with the client to explore project details and expectations, while we support you throughout the discussions and provide follow-up afterwards.
- Final interview & welcome – In a final chat with our team, we close the process and warmly welcome you to MindCapture, guiding you towards a smooth start with us or at the client site.
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Didn’t find the right match yet?
We know timing is everything. If you don’t see a role that fits you right now, we still want to hear from you. Our consultants are always looking for talent, sometimes before the job even goes live.
Drop us your CV and we’ll keep you in mind for future opportunities.
