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
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> physical/clinical work (Manufacturing Quality Systems)
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
