Responsibilities include:

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

The following criteria are considered minimums for the role:

• 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 reportin