Senior Quality Assurance Engineer
6 days ago
**MedTech Career Opportunity**
We are seeking an experienced Senior Quality Engineer to drive quality initiatives and ensure compliance with ISO 13485:2016.
This role focuses on CAPA management, risk assessment, supplier quality, and design control activities. Key Responsibilities:
- Lead Corrective and Preventive Action (CAPA) and Nonconformance Management
- Support design control activities and risk analysis (FMEA)
- Conduct Design Verification and Validation (V&V)
- Maintain and improve Quality Management System (QMS)
- Prepare and present quality metrics
About You: We're looking for a detail-oriented professional with experience in regulated industries.
We prefer candidates from medical device or pharmaceutical sectors but welcome applications from other regulated industries.
Skills & Experience:
- Bachelor's degree in Science, Engineering, or Technology
- Experience in a senior quality position (med device or pharma preferred)
- Strong knowledge of ISO 13485:2016
- Experience with QMS processes, risk management, CAPA, and nonconformance management
- Excellent technical writing and problem-solving skills
- Understanding of software development lifecycle (no coding required)
Benefits:
- Competitive salary that reflects your seniority
- Hybrid work model – spend time in our New Zealand office
- Join a well-funded, innovative startup with a collaborative team culture
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