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Senior Medical Device Quality Engineer - Design Controls Lead

Job in Newton, Middlesex County, Massachusetts, 02165, USA
Listing for: Ellenco Estágios e Treinamentos
Full Time position
Listed on 2026-07-31
Job specializations:
  • Engineering
    Quality Engineering
Salary/Wage Range or Industry Benchmark: 110000 - 170000 USD Yearly USD 110000.00 170000.00 YEAR
Job Description & How to Apply Below

Ellenco Estágios e Treinamentos seeks an experienced Senior Design Quality Engineer to support the development of complex robotic and electromechanical Class III medical systems. You will lead Design Controls, risk management, and V&V quality oversight to ensure regulatory compliance and robust product realization across the lifecycle.

You will collaborate with cross functional teams, manage CAPAs and document control, and ensure compliance with FDA QSR, ISO 13485, MDR/MDD, IEC 60601 family, and

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Position Requirements
10+ Years work experience
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