In-Process Quality Supervisor

Your challenge

•    Active leadership, supervision, and mentoring of direct reports. Tasks include goal setting and regular performance review for direct reports.
•    Coordinating daily operational activities to meet departmental Safety, People, Quality, Responsiveness, and Cost KPI’s.
•    Coordinating and performing IPQ inspection and release for 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.
•    Establishing clear procedures and documents compliant to Good Manufacturing Practice.
•    Supporting timely execution of Quality Assurance and Engineering validation activities including IQ, OQ, PQ, Product Verifications, Engineering Studies, Measurement Requests, etc. 
•    Supporting Regulatory Affairs by performing customer complaint investigations, change control, internal/external audits, and corrective actions.
•    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 recruiting, hiring, training and retraining for IPQ Leads and Inspectors.
•    The direct monitoring and management of employee compliance in accordance to GBO NA Safety, Quality, HR, and payroll policies.
•    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 the creation, revision, and distribution of IPQ documents. 
•    Responsible for the creation, revision, and distribution of testing plans in the IPQ Laboratory Information Management System (Babtec).

Your Profile

•    Associate’s Degree in Science, life sciences, or related field; Bachelor’s Degree is preferred
•    7 years of experience in an ISO 9001, ISO 13485, or similar regulated manufacturing environment; relevant leadership experience preferred.
•    5 years of direct Quality Control work 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