Quality Assurance Engineer – Medical Devices
SHL Medical · Taoyuan
Job description
About the role
The Quality Assurance Engineer will provide oversight across design, development, manufacturing and post‑market activities to ensure SHL Medical’s products meet regulatory requirements and customer expectations.
Key responsibilities
- Lead and participate in project‑related quality activities such as design control, change control and product release.
- Investigate non‑conformities observed during manufacturing and present quality data to customers and management.
- Identify trends using statistical tools and drive quality improvement initiatives.
- Support external quality inspections and conduct internal and supplier audits.
Required profile
- Bachelor’s degree in a relevant field or equivalent technical work experience.
- Strong logical thinking, organization and communication skills.
- Proficient problem‑solving abilities.
- Working knowledge of Microsoft Office.
Required skills
- Knowledge of GMP (Good Manufacturing Practice), QSR (Quality System Regulations) and ISO 13485.
- Familiarity with certifications such as CQT (Certified Quality Technician) or CQE (Certified Quality Engineer).
- Six Sigma Green Belt or Black Belt experience is a plus.
What we offer
- Challenging assignments in a fast‑growing, innovative medical‑device industry.
- Multicultural team, modern facilities and hybrid working policy with flexible hours.
- Opportunities for personal and professional development within a global organization.
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SHL Medical
Taoyuan
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