Overview
Quality Analyst – Area Sur Jobs in United States at Triple S
ROLES AND RESPONSIBILITIES
Complete any task assigned by the Quality Manager
Maintain clean and organized work area
Once all primary tasks are complete, assist other employees and departments as assigned by the Quality Manager or CEO
Complete continuing education requirements described during performance review
Complete and ensure proper execution of the Steri-Tek Quality Manual
Ensure that Steri-Tek follows ISO requirements and other regulatory standards including ISO 11137:2006 and AAMI TIR 29:2002.
JOB RECORD REVIEW
Review Job Records at specified intervals for accuracy and completeness (QA1, QA2, QA Approval, QA Final).
Ensure incoming products have been received and prepared for processing as described in Receiving & Pre-Processing Product for Irradiation Work Instruction (WI).
Contact customers as required to resolve any discrepancies with incoming product.
Review Run Records for accuracy and completeness and confirm processed product has been completed per specifications as described in WI – Job Record Review and Product Release.
Document Control
Ensure all SOP’s, forms, labels and other quality related documents are current and accurate. Initiate or review changes to controlled documents following document control SOP’s and WI’s.
Follow WI – Document Control when processing requests for the creation of new documents or changes to current documents.
Ensure all submitted Document Change Orders are complete and accurate.
Acquire approval from specific departments according to the chart on page 3 of WI – Document Control.
Acquire customer approval when needed.
Complete new documentation implementation and distribution.
Maintain all records associated with Document Control – both electronic and hard copy.
QMS MAINTENANCE
Assist the Quality Manager in Training, CAPA, Non-Conformance, Complaint, Calibration, Preventive Maintenance and Audit programs.
Send notifications or schedule appropriate activities for QMS programs.
Perform investigations, execute corrections.
Schedule and/or perform calibrations for equipment.
Schedule and/or perform preventive maintenance for equipment.
Manage due dates and implementation dates for QMS programs.
Collect and/or create any documentation required for QMS programs.
MINIMUM REQUIREMENTS/QUALIFICATIONS
High School Diploma or equivalent experience
Proficient in English language (written and spoken)
Microsoft Office
PREFERRED QUALIFICATIONS
Bachelor’s Degree or equivalent experience
Medical Device industry experience – 1-3 years
Steri-Tek is dedicated to providing a high-quality sterilization service and superior customer service to the industries that it serves. The QA Specialist ensures that Steri-Tek complies with all applicable regulatory standards including ISO 13485 and 11137, and that all Quality System Procedures are followed. Assist the Quality Manager in any activities required to maintain the effectiveness of the Steri-Tek Quality System.
Title: Quality Analyst – Area Sur
Company: Triple S
Location: United States
