Job Title: Quality Specialist
Pay: $28.00 - $33.00/hour
Position Summary: The Quality Specialist performs activities used to maintain quality processes required for Medical Device manufacturers and initial distributors including compliance with ISO, FDA, GMP, OSHA and similar regulatory quality requirements. Activities include, evaluation of corrective and preventive actions, auditing of various company departments, and functions that impact the safety and effectiveness of our products. This position requires understanding of IVD reagent manufacturing, and support processes.
- Performs day to day quality final product release function. Checks product quality; looks for defects, reviews and signs off on lot specific manufacturing documentation within Device History Record and SAP system software.
- Performs general quality system support for reagent production activities, includes assisting production department in daily inspections and completing exception or non-conformance paperwork when product/process issues are identified.
- Day to day management and coordination of appropriate and effective Corrective and Preventive Actions (CAPA) throughout the quality system in response to pertinent observations from the audit program, external regulatory agency inspections, and complaints.
- Develops and performs training programs at related to Quality Systems and internal procedures as part of document control system requirements.
- Performs internal audits and supplier audits as required to support the Quality System.
- Responsible for document and change control compliance. Processes new and revised documentation changes within document control system, includes paper based documentation requirements.
- Participates in customer complaint investigations for manufactured product.
- Assists in the tracking, gathering, and reporting of metrics that effectively measure and communicate quality system performance.
- BS in Science.
- 5-7 years of experience in Quality within an FDA regulated environment.
- Knowledge of cGMP (FDA QSR), ISO regulations. ASQ training / certification preferred.
- Microsoft Office software (Word, Excel, Powerpoint), SAP experience a plus.