Quality Control Technician

Job Description

The candidate will support the Post Market Vigilance Investigations team’s activities for the Patient Monitoring and Recovery (PMR) Division, including managing receipt of physical complaint product, coordinating investigations, performing Device History Record Reviews, root cause analysis on PMR product customer returns, managing medically applied device retains, and supporting staffing needs. The role also requires cleaning and decontamination of returned product samples, shipping samples to appropriate manufacturing locations, and daily lifting of biohazardous shipping boxes weighing up to 55 pounds.

The candidate will support the Post Market Vigilance Investigations team’s activities for the Patient Monitoring and Recovery (PMR) Division. These activities include assisting in managing the receipt of incoming physical complaint product, conducting follow-ups with accounts and/or International Subsidiaries to rectify discrepancies with product receipt, assisting in managing the process flow of complaint investigations, performing Device History Record Reviews, performing root cause analysis on PMR Product customer returns to ensure high levels of quality, reliability, safety, and efficacy, managing clinically applied medical device retains, and supporting staffing needs.

• Assist PMV Investigations Coordinator with managing receipt of physical complaint product samples, and corresponding with domestic and international accounts to rectify discrepancies in product receipt.
• Assist in the coordination of sanitization of clinically applied medical device returns and shipment to respective Medtronic Manufacturing facilities, and coordinate the investigation process with internal Engineering and Quality groups.
• Test and thoroughly evaluate clinically applied surgical medical devices of various degrees of complexity to determine root cause analysis within a closely monitored time frame.
• Identify the appropriate test method/regimen from existing Standard Operating Procedures for complaint sample evaluation, execute the method, and interpret the data for definitive root cause analysis determination. Test methods may include dimensional and/or tensile testing and interpretation of the technical data yielded in accordance with USP/EP/ASTM standards.
• Replicate reported failure mode with bench top or in vivo test methods and document observations accordingly.
• Initiate and distribute Corrective Action Requests to Manufacturing or Engineering Departments as needed.
• Prepare technical investigation reports based on evaluation results and/or review of the manufacturing plant reports to be documented in the QA department complaint database and incorporated into customer response letters.
• Maintain certification with OSHA’s Bloodborne Pathogens Standard 29 CFR  and adherence to Corporate and Local Environmental Health and Safety Policies.

• Minimum Experience:
  
  2 to 3 years.
• Academic or work experience in a laboratory or manufacturing environment. Experience with laboratory equipment or test equipment or manufacturing equipment highly desirable.
• Experience with medical devices preferred but not required.

• Must be proficient with MS Office (with emphasis on Excel and Word).
• Critical independent thinking and timely follow up.
• Excellent written and verbal skills necessary.

• Quality Assurance
• Research and Development
• Regulatory Affairs

Biohazardous laboratory environment requiring use of personal protective equipment in accordance with CDC and OSHA regulations.

Education:

BS Degree in a Science or Engineering discipline.