QC Supervisor - Injection Molding

The Quality Control Supervisor – Injection Molding (QC-IM Supervisor) is responsible for overseeing the daily operations of the Quality Control Injection Molding laboratories and manufacturing inspections. This includes managing QC-IM Team Leads and QC-IM Operators. The role reports to the QC-IM Manager and is accountable for ensuring compliance with Quality Management System policies and procedures, regulatory standards, and the inspection of injection molding products.

Responsibilities:

• Lead, supervise, and mentor direct reports, including goal setting and conducting regular performance reviews.
• Coordinate daily operational activities to meet departmental KPI targets for safety, personnel, quality, responsiveness, and cost.
• Oversee and perform quality control inspections and releases for incoming, semi-finished, and finished injection molding goods in line with established procedures.
• Provide direct oversight for the identification and management of nonconforming injection molding products.
• Conduct timely compliance reviews and close injection molding production batch records.
• Establish and maintain clear procedures and documentation in accordance with Good Manufacturing Practices (GMP).
• Execute injection molding Quality Assurance and Engineering validation activities, such as IQ (Installation Qualification), OQ (Operational Qualification), PQ (Performance Qualification), product verifications, engineering studies, and measurement requests.
• Support Regulatory Affairs by conducting investigations of customer complaints related to injection molding, managing change control, assisting with internal and external audits, and supporting corrective actions.
• Oversee the maintenance of QC-IM testing equipment in both laboratory and manufacturing areas, including troubleshooting, scheduling, and 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 operational readiness of QC-IM as required.

Authority:

• Recruit, hire, train, and retrain QC-IM Leads and Operators.
• Monitor and manage employee compliance with safety, quality, human resources, and payroll policies.
• Evaluate injection molding products, manage non-conforming products, and release QC-IM products according to established procedures.
• Oversee ERP transactions such as stock transfers, quality holds, and releases in SAP.
• Create, revise, and distribute QC-IM documents and testing plans in the QC-IM Laboratory Information Management System (LIMS).

Job Requirements:

• Associate’s Degree in Science, Life Sciences, or a related field (Bachelor’s Degree preferred).
• A minimum of 7 years of experience in an ISO 9001, ISO 13485, or similar regulated manufacturing environment, with relevant leadership experience preferred.
• At least 5 years of direct Quality Control experience.
• Intermediate experience with laboratory testing equipment, instrumentation, analysis, and laboratory data processing and review.
• 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 for detailed quality inspections as outlined in Standard Operating Procedures (SOPs) or Technical Procedures (TPs).