1 day ago

Site Quality Assurance Engineer

✓ Verified Job

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

Source: Company careers pageValidated by: Fursa AI

Last checked: 7 hours agoStatus: Live

Job Summary

Support the Quality Assurance organization by driving quality improvement across manufacturing and new product introductions. Lead product complaint investigations, perform health risk assessments, and participate in CAPA, change control, audits, and Material Review Board activities. Monitor production quality performance and analyze quality data to identify improvement opportunities. Work with R&D and regulatory teams to help ensure compliance with internal/external requirements, including GMP, ISO, and FDA regulations.

Location: United States

Workplace: Onsite

Employment Type: Full time

Job Function: QA, Test & Release Engineering

Seniority: Mid level

Key Responsibilities

•Collaborate across functions to solve problems, interpret data, and determine next steps.
•Lead product complaint investigations from receipt to resolution and complete health risk assessments.
•Develop and implement quality improvement programs and monitor production quality performance for improvement opportunities.
•Support manufacturing process validations and participate in change control for documents, manufacturing and QA/QC.
•Engage in audits, participate in CAPA as a trained CAPA lead, and ensure compliance with Quality System SOPs and GMP/ISO/FDA requirements.

Pay and Benefits

Salary: USD 75,000 - 95,000 annually

Key Requirements

•Requires a BS degree in a science or engineering related discipline.
•3+ years of related experience in a regulated environment, preferably medical device.
•Proficient at problem solving.
•Excellent verbal and written communication skills.
•Experience with ISO 13485, ISO 14971 and FDA QSR for Medical Devices; ASQ Certified Quality Engineer is desirable.

Experience:3+ yearsMedical deviceRegulated environment

Education:Bachelor's in Science or engineering related discipline

Skills:Problem-solvingVerbal communicationWritten communicationOrganizational skillsQuality improvement

Certifications:ASQ Certified Quality Engineer

Tech Stack:ISO 13485ISO 14971FDA QSRGood Manufacturing Practices (GMP)CAPAChange controlMaterial Review Board (MRB)Risk ManagementStatistical Analysis

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

Website LinkedIn

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ZOLL Medical

1 day ago

Site Quality Assurance Engineer

✓ Verified Job

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

Source: Company careers pageValidated by: Fursa AI

Last checked: 7 hours agoStatus: Live

Job Summary

Location: United States

Workplace: Onsite

Employment Type: Full time

Job Function: QA, Test & Release Engineering

Seniority: Mid level

Key Responsibilities

•Collaborate across functions to solve problems, interpret data, and determine next steps.
•Lead product complaint investigations from receipt to resolution and complete health risk assessments.
•Develop and implement quality improvement programs and monitor production quality performance for improvement opportunities.
•Support manufacturing process validations and participate in change control for documents, manufacturing and QA/QC.
•Engage in audits, participate in CAPA as a trained CAPA lead, and ensure compliance with Quality System SOPs and GMP/ISO/FDA requirements.

Pay and Benefits

Salary: USD 75,000 - 95,000 annually

Key Requirements

•Requires a BS degree in a science or engineering related discipline.
•3+ years of related experience in a regulated environment, preferably medical device.
•Proficient at problem solving.
•Excellent verbal and written communication skills.
•Experience with ISO 13485, ISO 14971 and FDA QSR for Medical Devices; ASQ Certified Quality Engineer is desirable.

Experience:3+ yearsMedical deviceRegulated environment

Education:Bachelor's in Science or engineering related discipline

Skills:Problem-solvingVerbal communicationWritten communicationOrganizational skillsQuality improvement

Certifications:ASQ Certified Quality Engineer

Tech Stack:ISO 13485ISO 14971FDA QSRGood Manufacturing Practices (GMP)CAPAChange controlMaterial Review Board (MRB)Risk ManagementStatistical Analysis

Company Brief

ZOLL Medical

Industry: Medical Devices

Company Size: Enterprise (1,001+ employees)

Growth: Established Company

Headquarters: Chelmsford, United States

Founded: 1980

Website LinkedIn