Quality Control Team Lead
Core
Lead a Quality Control team to ensure product quality meets Company standards and regulatory mandates (FDA, ISO, USDA) through testing, batch record review, and lab operations.
Role type
Senior IC Quality Control Team Lead
Builds
In-process and final release testing for medical device products
Domain
Healthcare / Medical Devices / Quality Assurance
Required skills
Laboratory operations, batch record review, regulatory compliance (FDA/ISO/USDA), team coordination, equipment calibration, quality incident initiation, SOP review/approval, technical troubleshooting, training and mentoring
Preferred skills
Medical device manufacturing experience, enzyme/immunochromatographic assays, laboratory statistics, data analysis, GMP regulations
Technologies
GMP, FDA, ISO, USDA regulations, laboratory equipment
Responsibilities
Coordinate and review in-process and final release testing; Plan and direct daily QC lab activities; Ensure effective shift transitions; Collaborate with cross-functional teams for timely product release; Train and mentor QC technicians; Calibrate and maintain lab equipment; Author and initiate Quality Incidents; Review and approve Standard Operating Procedures
Seniority
Senior, hands-on IC