Quality Assurance Engineer

ZOLL Medical
United States
Workplace: OnsiteFull timeUSD 75,000 - 95,000 annuallyFunction: QA, Test & Release EngineeringExperience: 3+ yearsEducation: bachelorsSkills: ["Problem-solving","Communication","Team collaboration","Analytical thinking","Attention to detail"]

Support the Quality Assurance organization by driving quality improvements, troubleshooting issues, and interfacing with R&D to support new product introductions. Lead investigations, monitor quality trends, and promote quality awareness across manufacturing and QA/QC, ensuring compliance with GMP, ISO, and FDA requirements while guiding process validations and CAPA activities.

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FursaFursa
ZOLL Medical
ZOLL Medical
7 months ago

Quality Assurance Engineer

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Source: Company careers pageValidated by: Fursa AI
Last checked: 3 hours agoStatus: Live

Job Summary

Support the Quality Assurance organization by driving quality improvements, troubleshooting issues, and interfacing with R&D to support new product introductions. Lead investigations, monitor quality trends, and promote quality awareness across manufacturing and QA/QC, ensuring compliance with GMP, ISO, and FDA requirements while guiding process validations and CAPA activities.
Location: United States
Workplace: Onsite
Employment Type: Full time
Job Function: QA, Test & Release Engineering

Key Responsibilities

  • •Lead product complaint investigations from receipt to resolution
  • •Complete health risk assessments from product complaints or internal product/process/system issues
  • •Develop and implement quality improvement programs
  • •Support planning, review and approval of manufacturing process validations
  • •Participate in change control activities for documents, manufacturing and QA/QC

Pay and Benefits

Salary: USD 75,000 - 95,000 annually

Key Requirements

  • •BS degree in science or engineering
  • •3+ years of experience in a regulated environment (preferably medical device)
  • •proficient at problem solving
  • •excellent verbal and written communication skills
  • •familiar with ISO 13485, ISO 14971 and FDA QSR for Medical Devices
Experience:3+ yearsMedical devicesHealthcare
Education:Bachelor's
Skills:Problem-solvingCommunicationTeam collaborationAnalytical thinkingAttention to detail
Certifications:ASQ Certified Quality Engineer
Languages:English
Tech Stack:Statistical AnalysisISO 13485FDA QSRGMP

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