Quality Technician

• This is a one year contract. Potential to convert to full time at the end of the one year.

The Quality Technician supports product quality activities with a primary focus on Verification & Validation (V&V) testing and New Product Introduction (NPI). This role works cross-functionally with R&D, Manufacturing, and Quality Engineering to ensure products meet design requirements, regulatory standards, and company quality objectives throughout the product lifecycle.

Key Responsibilities

Verification & Validation (V&V) Support

• Execute V&V test protocols, including functional, reliability, and performance testing
• Set up test fixtures, equipment, and test samples per approved procedures
• Accurately record, analyze, and report test data in accordance with GDP (Good Documentation Practices)
• Identify, document, and escalate nonconformances or unexpected results
• Support investigation and root cause analysis of test failures
• Partner with R&D during design and development phases to support product builds and testing. Assist in prototype builds, design iterations, and engineering studies
• Provide feedback on testability, manufacturability, and quality risks
• Ensure all activities comply with FDA, ISO 13485, and internal quality system requirements. Maintain accurate documentation, including test records, logs, and reports
• Assist with document control, including reviewing and updating procedures and test methods
• Ability to support projects as assigned.

Qualifications

Education & Experience

• Associate’s degree in a technical field (e.g., Engineering Technology, Life Sciences) or equivalent experience
• 2+ years of experience in a quality, manufacturing, or test role (medical device preferred)
• Experience with test execution and data collection in a regulated environment
• Familiarity with V&V processes and documentation. Working knowledge of FDA QSR (21 CFR Part 820) and/or ISO 13485
• Strong attention to detail and documentation accuracy. Ability to read and interpret engineering drawings and specifications
• Effective communication and teamwork skills
• Hands-on experience with lab/test equipment and measurement tools. Basic data analysis skills (Excel or similar tools)
• Experience with quality systems (eQMS) is a plus

Work Environment

• Combination of laboratory, manufacturing floor, and office settings
• May require lifting, standing for extended periods, and handling test equipment