Beckman Coulter Diagnostics · 9 hours ago
Senior Quality Assurance Engineer
Hialeah, FL
Full-time
Onsite
Senior Level
5+ years expBeckman Coulter Diagnostics is a global leader in clinical diagnostics, dedicated to improving patient health through innovative solutions. The Senior Quality Assurance Engineer will be part of the Miami Process Validation Group, specializing in validation deliverables and ensuring compliance with regulations and standards.
BiotechnologyHealth DiagnosticsLife ScienceManufacturing
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
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
Health care program
Paid time off
Company
Beckman Coulter Diagnostics
A global leader in advanced diagnostics, Beckman Coulter has challenged convention to elevate the diagnostic laboratory’s role in improving patient health for more than 80 years.
10001+ employees
H1B Sponsorship
Beckman Coulter Diagnostics 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 (34)
2024 (27)
2023 (27)
2022 (38)
2021 (26)
2020 (32)
Funding
Current Stage
Late StageTotal Funding
unknown2011-02-07Acquired
Leadership Team
Ruth Lyons
VP North America Marketing
Recent News
2025-12-18
2025-12-17
Company data provided by crunchbase