Manager, Quality Engineering
Core
Strategic and operational leadership for Quality Engineering, Calibration, and Inspection functions across multiple medical device manufacturing sites to ensure compliance, reduce Cost of Poor Quality (COPQ), and drive process capability.
Role type
Senior IC Quality Engineering Manager (Medical Devices)
Builds
Medical device components and finished medical devices
Domain
Medical device manufacturing / Quality Engineering
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure | physical/clinical work
Required skills
Quality Engineering principles, root cause analysis, risk management (PFMEA, ISO 14971), statistical process control (SPC), Design of Experiments (DOE), Measurement System Analysis (MSA), Lean Manufacturing, Six Sigma, calibration program management, regulatory compliance (ISO 13485, FDA 21 CFR Part 820)
Preferred skills
Multi-site leadership, ASQ CQE/CMQ/OE certification, Six Sigma Black Belt, Certified Lead Auditor
Technologies
Minitab, ERP systems, electronic quality systems
Responsibilities
Lead and develop quality engineering teams across multiple locations, drive COPQ reduction initiatives, lead quality investigations and CAPA activities, oversee calibration programs and metrology standards, support new product introductions and process transfers, serve as quality representative for customer audits and interactions, utilize statistical methods to evaluate process performance
Seniority
Senior, hands-on IC with strategic leadership
