Lead Quality System Technician
Core
Leads inspection activities on the manufacturing floor to ensure conformity of raw materials, components, and finished products to established standards and specifications.
Role type
Senior Quality Systems Lead Inspector
Builds
Ensures quality conformance for medical device/pharmaceutical manufacturing
Domain
Medical device / Pharmaceutical manufacturing
Required skills
Inspection techniques, GMP regulations, FDA/Health Canada facility knowledge, Root cause analysis, Calibration management, DHR compilation, Supplier evaluation, Statistical monitoring, Label control, Data analysis
Preferred skills
Medical device/pharma industry experience, ASQ/CQIA/CQPA/CQI/Lean/Green Belt certification, Bachelor's in scientific/engineering, Cross-functional collaboration
Technologies
Microsoft Office (Visio), Spreadsheets, Precision measuring equipment
Responsibilities
Lead coordination of inspection activities, Perform incoming material and finished product inspections, Maintain calibration services for inspection tools, Participate in cross-functional failure investigations, Review and compile Device History Records (DHR), Conduct QS internal audits, Assist with raw material testing in Chemistry Lab
Seniority
Senior, hands-on IC
