Quality Engineer

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We’re building the next generation of medical devices and looking for a driven, hands‑on Quality Engineer to help scale our quality and manufacturing operations from the ground up.

Quality Engineer – MedTech Startup

Join a fast-growing medical device startup where quality is at the core of everything we build. In this highly visible role, you will own key aspects of our Quality Management System (QMS) and work closely with engineering, operations, and manufacturing partners to bring innovative products to market.

This is an opportunity for someone who enjoys solving problems, building processes, and having a real impact in a dynamic startup environment.

What You’ll Do

• Own and continuously improve our QMS in compliance with ISO 13485 and regulatory requirements.
• Drive manufacturing quality activities with suppliers and contract manufacturers.
• Lead CAPA, non‑conformance, root cause investigations, and change control activities.
• Support process validation, quality controls, and product traceability.
• Participate in supplier audits and help prepare for regulatory inspections.
• Collaborate cross‑functionally with R&D, operations, and external partners to ensure product quality from development to production.

Why Join Us

• Work on meaningful technology with real patient impact.
• Be part of a small, ambitious, and collaborative team.
• Take ownership early and grow with the company.
• Flexible, entrepreneurial, and international environment.

What We’re Looking For

• Bachelor’s or Master’s degree in Engineering or a related technical field.
• 2–4 years of experience in Quality within medical devices or another regulated industry.
• Solid understanding of ISO 13485, supplier quality, CAPA, and manufacturing quality systems.
• Languages: English is mandatory, and Mandarin Chinese is a strong plus.
• Pragmatic, detail‑oriented, and comfortable taking ownership.
• Strong communication skills and ability to work in a fast‑paced environment.
• Startup mindset: adaptable, proactive, and eager to build.
• Willingness to travel occasionally to supplier sites and contract manufacturers in Europe and Asia.

• Initial screening (30 min) – HR team
• QMS interview (1.5 hr) – Quality Manager and Head of Manufacturing
• Final interview (1 hr) – On‑site meeting with top management