Product Quality Assurance Engineer

ZOLL Medical
United States
Workplace: HybridFull timeUSD 82,400 - 90,000 annuallyFunction: QA, Test & Release EngineeringExperience: 2+ yearsEducation: bachelorsSkills: ["Organizational skills","Attention to detail","Problem-solving","Collaboration","Written and verbal communication"]

Support product quality across the medical device lifecycle by leading or assisting complaint investigations, risk management updates, and product quality monitoring. Analyze complaint, service, and field performance data to identify trends and improvement opportunities, and help manage CAPA and nonconformance documentation and follow-ups. Partner with cross-functional teams (Engineering, Manufacturing, Regulatory, Post-Market) to support design review, verification/validation quality activities, and compliance with quality systems and regulations.

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FursaFursa
ZOLL Medical
ZOLL Medical
1 month ago

Product Quality Assurance Engineer

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI
Last checked: 14 days agoStatus: Live

Job Summary

Support product quality across the medical device lifecycle by leading or assisting complaint investigations, risk management updates, and product quality monitoring. Analyze complaint, service, and field performance data to identify trends and improvement opportunities, and help manage CAPA and nonconformance documentation and follow-ups. Partner with cross-functional teams (Engineering, Manufacturing, Regulatory, Post-Market) to support design review, verification/validation quality activities, and compliance with quality systems and regulations.
Location: United States
Workplace: Hybrid
Employment Type: Full time
Job Function: QA, Test & Release Engineering

Key Responsibilities

  • •Assist with product and complaint investigations, including data gathering and product failure analysis for root cause analysis.
  • •Support product risk management activities, including documentation updates, risk assessments, and risk management file maintenance.
  • •Analyze complaint, service, and field performance data to identify trends and recurring issues for quality improvements.
  • •Support CAPA and nonconformance activities, including documentation, tracking, and follow-up actions.
  • •Ensure quality activities comply with regulatory requirements and quality system/internal procedures, maintaining accurate quality records.
Travel: Low travel

Pay and Benefits

Salary: USD 82,400 - 90,000 annually

Key Requirements

  • •Bachelor's degree in engineering or a related technical discipline.
  • •2+ years of experience in quality engineering, product quality, or product engineering, preferably in a regulated industry.
  • •Internship/co-op/early career experience in medical devices, manufacturing, or a regulated industry.
  • •Experience using quality system tools or data analysis tools.
  • •Familiarity with complaint handling, CAPA, nonconformance systems, or risk management processes.
Experience:2+ yearsMedical devicesRegulated industryManufacturing
Education:Bachelor's
Skills:Organizational skillsAttention to detailProblem-solvingCollaborationWritten and verbal communication
Languages:English
Tech Stack:Risk managementCAPANonconformanceData analysisQuality system

Company Brief

ZOLL Medical
Designs and manufactures medical devices and software for critical care and rescue, including defibrillators, ventilators, CPR feedback systems, and monitoring solutions for hospitals, emergency responders, and public access settings.
Industry: Medical Devices
Company Size: Enterprise (1,001+ employees)
Growth: Established Company
Headquarters: Chelmsford, United States
Founded: 1980
WebsiteLinkedIn