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Quality Engineer

Job in Lexington, Middlesex County, Massachusetts, 02173, USA
Listing for: JobDiva, Inc.
Full Time position
Listed on 2026-10-07
Job specializations:
  • Engineering
    Quality Engineering, Process Engineer, Manufacturing Engineer, Biomedical Engineer
Salary/Wage Range or Industry Benchmark: 85000 - 120000 USD Yearly USD 85000.00 120000.00 YEAR
Job Description & How to Apply Below

Responsibilities:

  • This role will be responsible for ensuring the new catheter and console products and design changes to existing products meet regulatory and quality requirements throughout the design, development, and manufacturing transfer process.
  • This will be accomplished through close collaboration with cross-functional teams. The Quality Engineer participates in all phases of the product development process.
  • This includes development, reliability testing, design controls, input requirements, early design feasibility testing and verification and validation, manufacturing process development activities, product risk management requirements, and delivery.
Requirements :
  • Medical Device industry.
  • 3+ years of experience.
  • Complaint investigations.
  • CAPA's.
  • Evaluating nonconforming material.
  • Experience with catheters or sterile disposables.
  • Process Validation, IQ/OQ/PQ.
  • Design Control.
  • Risk Analysis.
  • FMEA.
  • Sustaining engineering.

This posting is for the Quality Engineer role at Job Diva, Inc., based in Lexington, MA, United States.

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