In Process Quality Team Lead

Your challenge

Responsibility:

The IPQ Team Lead is responsible for overseeing the daily monitoring and inspection of product during manufacturing. The IPQ Team Lead works under the guidance of the IPQ Supervisor and IPQ Manager and is responsible for ensuring compliance with Quality Management Systems policies and procedures, regulatory standards, and  inspection of GBO NA products. The role will be assigned to a 2-2-3 Twelve Hour Shift Schedule.

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.

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 IPQ Supervisor and Manager.
• The evaluation of products, control of non-conforming products, and IPQ release according to valid procedures.
• Responsible for ERP transactions such as stock transfers, quality hold and releases (SAP).
• Responsible for reporting and troubleshooting inspection devices/equipment and Laboratory Information Management System (Babtec).

Your Profile

Job Requirements:
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 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