Director Quality
Core
Lead a dynamic Quality Assurance team to ensure compliance with global regulations and standards for the development and manufacture of IVD products.
Role type
Director of Quality and Compliance (Medical Devices/IVD)
Builds
Quality Management Systems and compliant IVD products for global markets
Domain
Life Sciences / Clinical Diagnostics / Medical Devices
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality Management System (QMS) leadership, regulatory compliance strategy, audit management, risk-based decision making, cross-functional collaboration, talent development, financial planning
Preferred skills
Experience leading organizational transformation, MDSAP implementation, direct interaction with OEM partners
Technologies
ISO 13485:2016, US FDA QMSR, IVDD, IVDR, MDSAP
Responsibilities
Act as Management Representative for the Quality System and primary contact for all regulatory and customer audits; establish strategies to ensure QMS adequacy and sustained compliance; champion risk-based decision making throughout the product lifecycle; attract and develop top talent for the quality function; establish annual resource and financial plans; lead cross-functional teams for new product development and process improvement.
Seniority
Director, strategic leadership & team management
