Quality Control Team Lead - Injection Molding

Your challenge

12 Hour Days 7am - 7:30pm Rotating Schedule

•    Oversight of QC-IM team performance with escalations to QC-IM Supervisor.
•    Directly responsible mentoring and training QC-IM team members.
•    Coordinating daily operational activities to meet departmental Safety, People, Quality, Responsiveness, and Cost KPI’s.
•    Coordinating and performing QC inspection and release for incoming, semi-finished, and finished IM goods inspections according to valid procedure(s). 
•    Providing direct oversight for the identification and handling of nonconforming IM product according to valid procedure(s). 
•    Performing timely compliance review and closure of IM production batch records.
•    Accurately documenting and submitting QC and Production Batch records following Good Manufacturing Practice (GMP). 
•    Performing timely measurement and reporting for IM Quality Assurance and Engineering validation activities including IQ, OQ, PQ, Product Verifications, Engineering Studies, Measurement Requests, etc.
•    Supporting maintenance of QC-IM testing equipment in laboratory and manufacturing areas including troubleshooting, scheduling, and/or the performance of internal/external calibrations as required.
•    Performing periodic cycle counting and ordering of QC-IM laboratory supplies as needed. 
•    Performing other administrative duties to ensure QC-IM operational readiness as required.

Authority includes:
•    The direct monitoring and reporting of employee compliance in accordance to GBO NA Safety, Quality, HR, and payroll policies with management escalation to the QC-IM Supervisor and Manager.
•    The evaluation of IM products, control of non-conforming IM products, and QC-IM release according to valid procedures.
•    Responsible for ERP transactions such as stock transfers, quality hold and releases (SAP).
•    Responsible for reporting and troubleshooting QC-IM inspection devices/equipment and Laboratory Information Management System (Babtec).
 

Your Profile

•    High School diploma or GED; Associate’s Degree in Science, life sciences, or related field preferred
•    5 years of experience in an ISO 9001, ISO 13485, or similar regulated manufacturing environment
•    3 years of direct Quality Control experience
•    Intermediate-level experience with laboratory testing equipment, instrumentation, and analysis, as well as laboratory data processing and review
•    Intermediate-level MS office skills 
•    Intermediate-level knowledge of statistics, calculations, and reporting

Physical Requirements:
•    Must be able to stand and walk for up to 8-12 hours
•    Must be able to lift up to 50 lbs
•    Must have appropriate vision to perform detailed quality inspections as outlined in SOP’s or TP’s