parts, gages, and other equipment, accepting material/product or referring for quality review based on findings. Prepare inspection reports; ensure material traceability. Initiate Nonconformances (NCR) and Supplier Corrective Action Reports (SCARs); facilitate Material Review Board (MRB) meetings.
Use a variety of fixed and variable measuring instruments. Monitor and coordinate Engineering Change Order (ECO) activity across the organization ensuring compliance with the Quality Management System (QMS); support QMS maintenance for compliance with FDA QSR, ISO 13485, and other regulatory requirements. Ensure compliance with electronic document control workflows. Coordinate QA/QC tasks with
cross functional teams across the organization: support product development teams; review Device History Records (DHRs) for completeness and accuracy; execute receiving procedures & support shipping activities.
Support and promote continuous improvement initiatives to meet business objectives. Perform miscellaneous duties and projects as assigned and required. Training, Skills, Knowledge and/or Experience Demonstrated ability to manage records, document controls, and change controls. Experience using precision measuring equipment. Experience interfacing with stockroom, production control, purchasing, and engineering personnel. Working proficiency with Microsoft 365 apps, experience using
ERP/MRP/PLM systems preferred. Experience in FDA QSR and/or ISO 13485 or other regulated industry environments preferred.
Experience working in a product development environment a plus. Experience with QMS internal auditing and Minitab usage a plus. Education Requirements High School Diploma or GED required. Bachelor's degree or equivalent level of education preferred. Minimum of 3 years of QA/QC related experience required. PI9dd44cd026d For more details: jobs-search. org/information-technology_gardner-c434575/quality-assurance-specialist-gardner_i1976023456
