Senior Staff Quality Engineer
$133.4k - $222.3kStryker Orthopaedics
Senior Staff Quality Engineer role within the Endoscopy division focused on providing quality engineering leadership, technical guidance, and mentorship. Responsibilities include driving quality initiatives, managing nonconformances and corrective actions, and ensuring regulatory compliance across products and processes.
Responsibilities
- Mentor staff and provide technical direction across multiple quality expertise areas
- Lead quality initiatives and projects to enhance performance and customer outcomes
- Oversee and approve nonconformance and CAPA activities with expert problem-solving
- Manage audit preparation and engagement with regulatory representatives and agencies
- Drive continuous improvement by analyzing KPI trends and implementing mitigation strategies
Requirements
- Bachelor's degree in science, engineering, or related discipline
- Minimum 6 years quality and/or R&D experience in medical device industry
- Strong knowledge of ISO 13485, GDP, GMP, and medical device regulations
- Experience leading root cause investigations, CAPA, and complaint activities
- Expertise in nonconformance management and post-market quality initiatives
Compensation: $133,400 - $222,300 USD Annual
Vacancy posted 10 days ago
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