Quality Engineer

Quality Engineer - Electromechanical Medical Devices (Contract)

Boston, MA | Onsite
5 Month Contract | W2 Only
Start Date: February 2, 2026

About the Role

This role is ideal for a hands‑on Quality Engineer who thrives on the production floor, excels at root‑cause investigation, and drives operational excellence across electromechanical assembly and test processes.

You'll partner closely with Quality, R&D, Manufacturing Engineering, and Supplier Quality to ensure product reliability, regulatory compliance, and continuous improvement.

Key Responsibilities

Quality Engineering

• Provide day‑to‑day quality engineering support for electromechanical medical device manufacturing, including assembly, calibration, and functional testing.
• Lead and execute investigations for nonconformances, deviations, CAPAs, and complaints, ensuring timely closure and effective corrective actions.
• Support verification and validation (V&V) activities, including test method validation for electrical and mechanical components.
• Perform risk management activities (FMEA, PFMEA, DFMEA) to ensure robust design and process controls.

Manufacturing & Process Support

• Serve as a true "Green Line Guru", providing hands‑on, real‑time support on the manufacturing floor.
• Troubleshoot issues involving electronics, firmware interfaces, wiring, PCB assemblies, sensors, actuators, and mechanical components.
• Partner with Manufacturing Engineering to optimize assembly steps, inspection criteria, and test methods.
• Author and revise work instructions, inspection procedures, and quality documentation.

Compliance & Documentation

• Ensure compliance with FDA 21 CFR 820, ISO 13485, and other applicable medical device regulations.
• Execute quality documentation including ECOs, DHF/DMR updates, and Device History Record (DHR) reviews.
• Support internal and external audits as required.

Supplier & Component Quality

• Collaborate with Supplier Quality to evaluate component issues, inspection results, and supplier nonconformances (NCRs).
• Support incoming inspection setup and controls for electromechanical components.

Required Experience & Skills

• 5+ years of experience as a Quality Engineer within the medical device industry, preferably supporting electromechanical systems.
• Strong working knowledge of mechanical assemblies AND electrical/electronic systems, including PCBs, cables, and embedded components.
• Proven hands‑on troubleshooting capabilities; comfortable working directly on the manufacturing floor.
• Experience with CAPA, nonconformances, complaint handling, and root cause analysis tools (5 Whys, Fishbone, DMAIC).
• Working knowledge of FDA 21 CFR 820, ISO 13485, ISO 14971, and GMP/GDP principles.
• Experience supporting V&V testing and test method validation.
• Ability to read and interpret engineering drawings, schematics, wiring diagrams, and inspection criteria.
• Strong communication, documentation, and cross‑functional collaboration skills.