QUALITY CONTROL TECHNICIAN

Infoway Group; Mansfield (MA); On-site; USD 55,000 - 75,000; Full time

Job summary

Infoway Group in Mansfield, Massachusetts is seeking a candidate to support the Post Market Vigilance Investigations team in the Patient Monitoring and Recovery Division. Responsibilities include managing physical complaint products, coordinating investigations, and performing root cause analysis.

The ideal candidate will have 2-3 years of experience in a lab or manufacturing setting, proficiency in MS Office, and possess a BS in a science or engineering discipline. This role operates in a biohazardous environment requiring safety gear.

Qualifications

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

Responsibilities

• Manage receipt of physical complaint product samples.
• Coordinate investigations and conduct follow-ups with accounts.
• Perform Device History Record Reviews and root cause analysis.

Skills

Proficient with MS Office (Excel and Word)

Critical independent thinking

Excellent written and verbal skills

Education

BS Degree in a Science or Engineering discipline

Tools

Laboratory equipment

Test equipment

Manufacturing equipment

Job description

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.

Summary of Position

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.

Essential Functions

• 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 1910.1030 and adherence to Corporate and Local Environmental Health and Safety Policies.

Minimum Requirements

• 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.

Skills / Qualifications

• 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.

Organizational Relationships / Scope

• Quality Assurance
• Research and Development
• Regulatory Affairs

Working Conditions

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

Qualifications

Education: BS Degree in a Science or Engineering discipline.