Qms/ Qa Specialist Jobs

The Quality Specialist ensures Steri-Tek complies with all applicable regulatory standards including ISO 13485 and 11137, and that all Quality System Procedures are followed in an accurate manner. Assist the Quality Manager in any activities required to maintain the effectiveness of the Steri-Tek Quality System. Below are the primary responsibilities for this position. Additional responsibilities such as project management will be also assigned at the discretion of the Quality Manager and/or Assistant Quality Manager.

Core responsibility

• Complete continuing education requirements described during performance review
• Ensure that Steri-Tek follows ISO requirements and other regulatory standards including ISO 11137:2006 and AAMI TIR 29:2002
• Review Job Records at specified intervals for accuracy and completeness for QA final check
• Complete and ensure proper execution of the Steri-Tek Quality Manual
• Maintain clean and organized work area
• Complete any task assigned by the Quality Manager
• GDP corrections and document archiving
• Review documentation in job records

JOB RECORD REVIEW

• Contact customers as required to resolve any discrepancies with incoming product
• Review Job Records at specified intervals for accuracy and completeness (QA1, QA2 (when applicable), 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)
• 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

• 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
• 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
• 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

• Send notifications or schedule appropriate activities for QMS programs
• Schedule and/or perform calibrations for equipment
• Collect and/or create any documentation required for QMS programs
• Manage due dates and implementation dates for QMS programs
• Assist the Quality Manager in Training, CAPA, Non-Conformance, Complaint, Calibration, Preventive Maintenance and Audit programs
• Perform investigations, execute corrections
• Schedule and/or perform preventive maintenance for equipment

Other duties as assigned.

Requirements

MINIMUM REQUIREMENTS/QUALIFICATIONS

• High School Diploma or equivalent experience
• Proficient in English language (written and spoken)
• Microsoft Office

Preferred Qualifications

• Medical Device industry experience – 1-3 years
• Bachelor’s Degree or equivalent experience

Benefits

Steri-Tek offers medical, dental, vision, 401K with matching, and paid holiday and paid time off.

Work schedule: Day shift, working Monday - Friday, 10:00 AM - 7:00 PM. Note: training will be from 8:00 AM - 4:30 PM or 8:30 AM - 5:00 PM from Monday to Friday for about 4-8 weeks.