54 applicants

Company

Edwards Lifesciences · 6 hours ago

Quality Engineer I – Product Post Market Surveillance (THV)

USA

Full-time

Remote

Entry Level

$66K/yr - $93K/yr

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BiotechnologyHealth Care

Comp. & Benefits

H1B Sponsor Likely

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Responsibilities

Investigate manufacturing product quality and compliance issues reported from the field, analyze results, determine root cause/probable cause, and initiate and review reports.

Perform assessment for similar incident reportable complaints to identify rate and possible escalation.

Assess reported events against established risk documentation for clinical and compliance risk(s) and escalate to Quality Management and Product Safety as needed.

Participate in escalation tasks and activities, including Project Risk Assessments (PRA) and Corrective/Preventive action(s) – CAPAs, SCARs, as determination by investigation.

Identify and report key complaint metrics per device category and collaborate with applicable manufacturing engineering teams to resolve production/device related issues.

Assist in ad hoc complaint analysis or metric review.

Perform other duties and responsibilities as assigned.

Qualification

Find out how your skills align with this job's requirements. If anything seems off, you can easily click on the tags to select or unselect skills to reflect your actual expertise.

Medical Device experienceProduct complaints investigationRoot cause analysisEngineeringNCRsFMEAsCAPAsProduct Risk AssessmentsClass III cardiovascular devicesLifesciences industry experienceComplaint documentation reviewTechnical investigation reportsRisk managementManufacturing product qualityAssessment for complaintsEscalation tasksKey complaint metricsAd hoc complaint analysis

Required

Bachelor's in Engineering or Scientific field.

Preferred

Medical Device, Pharma, Biotech, or other Lifesciences industry experience.

Experience with product or device complaints, investigations, and/or root cause analysis.

Experience with NCRs, FMEAs, CAPAs, or Product Risk Assessments.

Familiar with key technologies and processes related to the assembly and manufacture of Class III cardiovascular devices and delivery systems.

Benefits

Competitive salaries

Performance-based incentives

A wide variety of benefits programs

Company

Edwards Lifesciences

Glassdoor

4.0

Edwards Lifesciences is a provider of science of heart valves and hemodynamic monitoring.

Founded in 1958

Irvine, California, USA

10,001+ employees

http://www.edwards.com

H1B Sponsorship

Edwards Lifesciences has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

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Trends of Total Sponsorships

2023 (36)

2022 (69)

2021 (53)

2020 (32)