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Quality Engineer II

Job in North Haven, New Haven County, Connecticut, 06473, USA
Listing for: Artech
Full Time position
Listed on 2026-09-03
Job specializations:
  • Quality Assurance - QA/QC
    Quality Engineering, Regulatory Compliance Specialist
  • Engineering
    Quality Engineering, Regulatory Compliance Specialist
Job Description & How to Apply Below

Quality Engineer II

Must-Have

Skills:

  • 3–5 years of Quality Engineering experience in a regulated industry (Medical Device preferred).
  • Design Quality experience:
    Design Controls, Risk Management (FMEA), Requirements Traceability.
  • QMS knowledge: CAPA, Change Management, Document Control.
  • Data analysis, Root Cause Analysis (Fishbone, Pareto, 5 Whys), basic SPC/statistical tools.

Key Responsibilities:

  • Support Design Quality activities for the Hugo RAS product line.
  • Develop and maintain quality documentation, standards, and protocols.
  • Collaborate with Engineering and Manufacturing on product/process quality.
  • Investigate nonconformances, perform root cause analysis, and implement corrective actions.
  • Conduct inspections, quality testing, statistical analysis, and ensure regulatory compliance.

Education:

  • Bachelor's degree in Engineering (preferred) or related technical field.
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