Senior Quality Assurance Engineer jobs in United States
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Danaher Corporation · 5 hours ago

Senior Quality Assurance Engineer

positionHialeah, Florida, United States
timeFull-time
remoteOnsite
senioritySenior Level
date5+ years exp

Danaher Corporation's Beckman Coulter Diagnostics is a global leader in clinical diagnostics, committed to improving patient health through innovative solutions. The Senior Quality Assurance Engineer will be a key member of the Miami Process Validation Group, responsible for ensuring compliance and quality in instrument manufacturing through various validation processes.

BiotechnologyHealth CareHealth DiagnosticsLife ScienceMedical
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H1B Sponsor Likelynote

Responsibilities

Write and conduct IOQ and spreadsheet validations
Complete PQ, TMV, AQ, and NPSV validations
Manage process and product non-conformances in line with company procedures
Develop, maintain, monitor, and audit quality management system and protocols, including systems automation, processes, and procedures that ensure compliance with regulations and standards

Qualification

Process ValidationQuality Management SystemsCFR 21 Part 820ISO 13485Microsoft ExcelGamp5 ExposureASQ Certified Quality EngineerComputer ProgrammingSoft Skills

Required

Bachelor's degree in engineering (mechanical, electrical, chemical, bioengineering, or a related area) and 5+ years of experience in the medical device industry
Familiarity with CFR 21 Part 820 and ISO13485
Proficiency in Microsoft Excel and a good working knowledge of computer programming and systems

Preferred

Knowledge of PQ, TMV, AQ, NPSV validations
Exposure to Gamp5 or similar regulations
ASQ Certified Quality Engineer (CQE)

Benefits

Comprehensive, competitive benefit programs
Health care program
Paid time off

Company

Danaher Corporation

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Danaher is a leading global life sciences and diagnostics innovator, committed to accelerating the power of science and technology to improve human health.
dateFounded in 1969
location
Washington, District of Columbia, USA
people-size10001+ employees
web-link
https://www.danaher.com/

H1B Sponsorship

Danaher Corporation 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
Represents job field similar to this job
Trends of Total Sponsorships
2025 (7)
2024 (4)
2023 (3)
2022 (1)
2021 (2)
2020 (1)

Funding

Current Stage
Public Company
Total Funding
unknown
1979-01-05IPO

Leadership Team

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Rainer Blair
President & CEO
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Thomas Joyce
President & CEO

Recent News

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thefly.com
Danaher sees Q4 revenue growth in mid-single digit percent range y/y
2026-01-13
Company data provided by crunchbase