Sr. Manager Quality Assurance
Core
Strategic leadership and oversight of manufacturing operations to ensure compliance with FDA, EU GMP, and ISO 13485 regulations for surgery products.
Role type
Senior Manager, Quality Assurance (Medical Device Manufacturing)
Builds
Compliant manufacturing processes and quality systems for surgery products
Domain
Medical Technology / Surgical Devices
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP compliance (21 CFR 210/211, 820), EU GMP, ISO 13485, risk-based decision-making, CAPA management, deviation handling, change control, complaint management, regulatory inspection readiness, data analysis, Lean/Six Sigma, SAP proficiency
Preferred skills
Master's degree in Engineering or Science, Pharmaceutical manufacturing experience, FDA inspection experience (483s, Warning Letters), succession planning
Technologies
SAP
Responsibilities
Ensure adherence to cGMP requirements and regulatory standards; Provide independent quality oversight of manufacturing operations including in-process controls and batch record review; Drive risk-based decision-making and continuous improvement initiatives; Lead, coach, and develop a high-performing QA organization; Manage departmental budget and resources; Serve as SME during internal and external regulatory inspections
Seniority
Senior, hands-on IC with people management