Director, Quality Operations
Core
Manage site-level Quality System compliance for medical device manufacturing, ensuring adherence to US FDA, ISO 13485, and other regulatory requirements while leading a team of Quality Engineers, Control, and Assurance associates.
Role type
Director, Quality Operations (Site Leadership)
Builds
Medical device manufacturing operations (OmniPod platform)
Domain
Medical Device Manufacturing / Regulatory Compliance
Required skills
Quality Management Systems (QMS) design and implementation, FDA 21 CFR Part 820 and ISO 13485 compliance, CAPA system management, statistical quality control processes, risk-based decision making, team leadership and mentorship, cross-functional collaboration, data analytics interpretation
Preferred skills
High-volume electromechanical device manufacturing experience, global matrix organization experience, Environmental Health and Safety (EHS) initiative leadership
Technologies
Microsoft Word, Excel, Data Analytics tools, Power BI
Responsibilities
Lead a team of Quality Engineers, QC, and QA associates; establish and maintain strategies for quality objectives and regulatory compliance; manage internal and external QMS audits; ensure effectiveness of CAPA and Quality Planning processes; oversee product release based on Device Master Record requirements; manage the budget for Quality Assurance Operations; partner with global stakeholders for standardization and continuous improvement.
Seniority
Director, strategic leadership and team management