What are the responsibilities and job description for the Quality Supervisor position at ClinLab Staffing?
Quality Supervisor
Monroe, NC
Full-Time, Permanent
This role reports to the In-Process Quality Manager and is responsible for ensuring compliance with Quality Management Systems policies and procedures, regulatory standards, and inspection of all products. The role will be assigned to a 2-2-3 Twelve Hour Shift Schedule.
Responsibilities include:
- 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 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).
Job Requirements:
- 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
