Job Title: Quality Control Team Lead – Injection Molding

Location: North Carolina

Salary: $110k

The Quality Control Team Lead – Injection Molding (QC-IM Team Lead) is responsible for managing the daily operations of the Quality Control Injection Molding laboratories and manufacturing inspections. The QC-IM Team Lead works under the guidance of the QC-IM Supervisor and Manager, ensuring compliance with Quality Management System policies, regulatory standards, and overseeing the inspection of injection molding products.

Responsibilities:

• Oversee the performance of the QC-IM team and escalate issues to the QC-IM Supervisor as needed.
• Mentor and train QC-IM team members to ensure effective performance.
• Coordinate daily operational activities to meet departmental Key Performance Indicators (KPIs) for safety, personnel, quality, responsiveness, and cost.
• Perform and oversee QC inspections and releases for incoming, semi-finished, and finished injection molding goods according to established procedures.
• Supervise the identification and handling of nonconforming injection molding products.
• Conduct timely reviews and closure of injection molding production batch records.
• Document and submit QC and production batch records in compliance with Good Manufacturing Practices (GMP).
• Measure and report data for injection molding Quality Assurance and Engineering validation activities, including IQ (Installation Qualification), OQ (Operational Qualification), PQ (Performance Qualification), product verifications, engineering studies, and measurement requests.
• Support the maintenance of QC-IM testing equipment in laboratory and manufacturing areas by troubleshooting, scheduling, and/or performing internal/external calibrations.
• Perform periodic cycle counting and manage the ordering of QC-IM laboratory supplies as needed.
• Complete other administrative duties to ensure the operational readiness of QC-IM as required.

Authority:

• Monitor and report employee compliance with safety, quality, human resources, and payroll policies, escalating to the QC-IM Supervisor and Manager when necessary.
• Evaluate injection molding products, control non-conforming products, and release QC-IM products according to valid procedures.
• Manage ERP transactions such as stock transfers, quality holds, and releases in SAP.
• Report and troubleshoot issues with QC-IM inspection devices/equipment and Laboratory Information Management Systems (LIMS).

Job Requirements:

• High School diploma or GED required; Associate’s Degree in Science, Life Sciences, or a related field preferred.
• Minimum of 5 years of experience in an ISO 9001, ISO 13485, or similar regulated manufacturing environment.
• At least 3 years of direct Quality Control experience.
• Intermediate-level experience with laboratory testing equipment, instrumentation, analysis, and data processing.
• Proficiency in MS Office applications.
• Intermediate knowledge of statistics, calculations, and reporting.

Physical Requirements:

• Ability to stand and walk for 8-12 hours.
• Ability to lift up to 50 lbs.
• Vision acuity sufficient to perform detailed quality inspections as outlined in Standard Operating Procedures (SOPs) or Technical Procedures (TPs).