Post-Market Quality Technician

Post-Market Quality Technician (Medical Devices)

Pay Rate: $32.00/hour

Employment Type: Contract

Department: Quality

Position Overview

We are seeking a detail-oriented Post-Market Quality Technician to support hands-on investigations of FDA-approved medical devices. This role is a key contributor within the Quality Department, focused on product testing, data analysis, and maintaining compliance with regulatory standards. The ideal candidate thrives in a structured, fast-paced environment and brings strong organizational skills, technical curiosity, and a commitment to quality.

Key Responsibilities

Quality Testing & Analysis

• Perform product testing and basic failure analysis on returned devices
• Troubleshoot new and emerging failure modes
• Collect, log, and analyze quality data to identify trends

Quality Systems & Documentation

• Generate, review, and maintain quality system records (training, audits, NCRs, CAPAs)
• Review Lot Acceptance Records and Device History Records (DHRs)
• Ensure accuracy and completeness of data entry and documentation
• Support FDA and ISO 13485 inspections by gathering required information

Collaboration & Process Improvement

• Partner with Quality Assurance Engineers and cross-functional teams to maintain effective inspection and testing procedures
• Evaluate process and engineering controls to improve product safety and efficiency
• Contribute to continuous improvement initiatives

Qualifications

Required

• Associate's degree in Engineering, Science, or related discipline
• Strong attention to detail and organizational skills
• Proficiency in Microsoft Office, particularly Excel
• Ability to manage tasks independently and maintain accurate records

Preferred

• 2+ years of experience in a quality-related role
• Experience in a regulated environment (medical device preferred)
• Familiarity with ISO 13485, QSR, or similar quality systems
• Electrical and/or mechanical background
• Experience working in a lab or biohazard environment
• Knowledge of Lean Six Sigma methodologies
• Experience creating and analyzing charts, including Pareto charts

Key Skills

• Data analysis and documentation accuracy
• Technical writing and record-keeping
• Problem-solving and troubleshooting
• Strong communication and teamwork abilities

Work Environment & Physical Requirements

• Combination of lab and office environment
• Sitting approximately 70% of the time; standing 30%
• Frequent lifting under 5 lbs; occasional lifting up to 50 lbs
• Ability to operate basic hand tools

Benefits

We offer a comprehensive benefits package including medical, dental, and vision insurance, 401(k), employee assistance programs, commuter benefits, employee discounts, and more.

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