Sr. Director, Quality, Genetics Sciences Division (GSD)
Core
Leading global Quality operations for 8 sites and 130+ team members, ensuring compliance and driving quality strategy for medical device and regulated product lifecycles.
Role type
Sr. Director, Quality
Builds
Global Quality Management Systems (QMS) and compliance frameworks for medical devices and regulated products.
Domain
Medical Device / Life Sciences / Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Quality Management Systems (QMS), regulatory compliance (21 CFR 820, ISO 13485, MDSAP), multi-site operations leadership, strategic quality planning, risk management (FMEA, RCA), Lean Six Sigma, cross-functional project leadership, data analysis for quality improvement.
Preferred skills
New Product Introduction (NPI) support, establishing QMS for RUO and Regulated products, operational and strategic leadership, quality engineering and improvement.
Technologies
TrackWise, AGILE, E1/SAP, LIMS
Responsibilities
Lead global Quality functions across manufacturing operations; advise leadership on product quality and regulatory strategies; drive quality plans to improve product fit and customer experience; manage matrix peer relationships for network compliance; support commercial business and revenue growth; mentor and coach team members; conduct advanced data analyses to identify quality improvements.
Seniority
Senior, hands-on IC