Overview In this role you drive quality leadership for the Endoscopy division in San Jose, focusing on QA, process control, and preventive activities to boost product and process performance. You will partner with cross-functional teams to address top quality issues and advocate continuous improvement initiatives. You mentor experts, oversee regulatory-compliant quality systems, and guide audits and change management. Your work enables safer products, faster issue resolution, and stronger customer trust. This is a hands-on opportunity to shape quality culture in a global medical device leader.
Compensation / Benefits- hybrid work arrangement
- travel 10%
Responsibilities- Collaborate with customers, field personnel, and cross-functional teams to resolve key quality issues
- Mentor and approve NC/CAPA processes and lead root-cause analysis activities
- Lead quality initiatives and projects and act as process owner across multiple quality areas
- Contribute to local, global, and corporate processes and participate on review boards
- Review and approve change management activities and assess effectiveness
- Analyze KPI trends and drive continuous improvement
- Advocate Human Factors practices and mitigation strategies
- Engage in audits with regulatory representatives, including audit logistics and preparation
- Initiate and support containment and holds for potential product escapes
- Coach others in quality topics and activities
Key requirements- Bachelor's degree in a science, engineering or related discipline
- Minimum 6 years in Quality and/or R&D within the medical device industry
- Strong knowledge of ISO 13485, GDP, GMP, post-market requirements, and U.S./international regulations
- Experience leading root cause investigations, CAPA, complaint investigations, and post-market quality initiatives
- Cross-functional collaboration
- Mentoring and coaching
- Problem-solving and analytical thinking
- Quality systems and design controls
- Risk management
- CAPA and nonconformance management
