Steri-Tek is dedicated to providing a high-quality sterilization service and superior customer service to the industries that it serves.

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. Assists 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 CEO.

ROLES AND RESPONSIBILITIES

• Completes any task assigned by the Quality Manager
• Maintains clean and organized work area
• Once all primary tasks are complete, assists other employees and departments as assigned by the Quality Manager or CEO
• Completes continuing education requirements described during performance review
• Completes and ensures proper execution of the Steri-Tek Quality Manual
• Ensures that Steri-Tek follows ISO requirements and other regulatory standards including ISO 11137:2006 and AAMI TIR 29:2002
• Ensures incoming products have been received and prepared for processing as described in Receiving & Pre-Processing Product for Irradiation Work Instruction (WI)
• Contacts customers as required to resolve any discrepancies with incoming product
• Reviews Run Records for accuracy and completeness and confirms processed product has been completed per specifications as described in WI - Job Record Review and Product Release

JOB RECORD REVIEW

• Reviews Job Records at specified intervals for accuracy and completeness (QA1, QA2 (when applicable), QA Approval, QA Final)
• Ensures incoming products have been received and prepared for processing as described in Receiving & Pre-Processing Product for Irradiation Work Instruction (WI)
• Contacts customers as required to resolve any discrepancies with incoming product
• Reviews Run Records for accuracy and completeness and confirms processed product has been completed per specifications as described in WI - Job Record Review and Product Release

DOCUMENT CONTROL

• Ensures all SOP’s, forms, labels and other quality related documents are current and accurate. Initiates or reviews changes to controlled documents following document control SOP’s and WI’s
• Follows WI - Document Control when processing requests for the creation of new documents or changes to current documents
• Ensures all submitted Document Change Orders are complete and accurate
• Acquires approval from specific departments according to the chart on page 3 of WI - Document Control
• Acquires customer approval when needed
• Completes new documentation implementation and distribution
• Maintains all records associated with Document Control – both electronic and hard copy

QMS MAINTENANCE

• Assists the Quality Manager in Training, CAPA, Non-Conformance, Complaint, Calibration, Preventive Maintenance and Audit programs
• Sends notifications or schedules appropriate activities for QMS programs
• Performs investigations and executes corrections
• Schedules and/or performs calibrations for equipment
• Schedules and/or performs preventive maintenance for equipment
• Manages due dates and implementation dates for QMS programs
• Collects and/or creates any documentation required for QMS programs

Requirements

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

Work schedule: Monday - Friday with weekend overtime. Regular working hours are 10:30am - 7:00pm, but training is from 8:30am - 5:00pm.

Pay rate range: $23 - $25 per hour

Benefits

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