Quality Assurance Engineer; Expert Level
Job in
Hebron, Boone County, Kentucky, 41048, USA
Listed on 2026-06-02
Listing for:
TalentBurst, Inc.
Full Time
position Listed on 2026-06-02
Job specializations:
-
Engineering
Quality Engineering, QA Specialist / Manager -
Quality Assurance - QA/QC
Quality Engineering, QA Specialist / Manager, Quality Control / Manager
Job Description & How to Apply Below
Job Title:
Quality Assurance Engineer (Expert Level)
Location:
Hebron KY
Duration: 12 months
Job Description:
The Quality Assurance Engineer is part of the Process Validation Group, specializing in all types of validation deliverables.
The Quality Assurance engineer is a key member of the PV team, reporting to the Senior Manager, Process Validation. You will collaborate with senior QA staff, taking responsibility for Process Validation Reagents within Reagent manufacturing.
In this role, you will have the opportunity to:
- Write and conduct IOQ and spreadsheet validations.
- Complete PQ, TMV, AQ validations.
- Develop, maintain, monitor, and audit quality management system and protocols, including systems automation, processes, and procedures that ensure compliance with regulations and standards.
- 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 ISO
13485. - Proficiency in Microsoft Excel and a good working knowledge of computer programming and systems.
- Knowledge of PQ, TMV, AQ, NPSV validations.
- Exposure to Gamp5 or similar regulations.
- ASQ Certified Quality Engineer (CQE).
#ZR
Why Talent Burst?
At Talent Burst, we deliver more than talent, we deliver outcomes. We partner with you to move quickly and connect you to opportunities aligned with your skills and long term growth.
Backed by precision, transparency, and results, we connect top talent with leading organizations through trusted partnerships.
We offer competitive compensation and comprehensive benefits, including medical, dental, vision, and retirement options.
Talent Burst is an equal opportunity employer committed to an inclusive and diverse workforce.
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