Associate Manager, Quality Engineering
Core
Lead a team of Quality Engineers and Technicians to oversee quality programs, complaint handling, and post-market surveillance for medical devices.
Role type
Associate Manager, Quality Engineering (Leadership)
Builds
Quality systems, complaint handling processes, and post-market surveillance activities for Stryker Emergency Care devices.
Domain
Medical Devices / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Team leadership, talent strategy, KPI management, cross-functional partnership, data analysis, process improvement, budget management, audit support
Preferred skills
Managing technical teams, US/international medical device regulations (21 CFR Part 820, ISO 13485, ISO 14971), process improvement, complaint handling, post-market quality initiatives
Technologies
21 CFR Part 820, ISO 13485, ISO 14971
Responsibilities
Own talent strategy including hiring and succession planning; Lead and develop a team of Quality Engineers and Technicians; Represent Stryker in customer-facing quality discussions; Establish and monitor KPIs and quality objectives; Partner with cross-functional teams to resolve quality issues; Analyze complaint and product quality data; Lead development of complaint handling and post-market surveillance processes; Support internal and external audits; Manage departmental budgets and warranty costs
Seniority
Manager, hands-on leadership