More jobs:
Engineering - Engineer - Quality Assurance; Expert Level
Job in
Hebron, Boone County, Kentucky, 41048, USA
Listed on 2026-06-03
Listing for:
LanceSoft Inc
Full Time
position Listed on 2026-06-03
Job specializations:
-
Engineering
Quality Engineering, QA Specialist / Manager -
Quality Assurance - QA/QC
Quality Engineering, QA Specialist / Manager
Job Description & How to Apply Below
Duration: 0-12+ Months
Shift: 1st Shift M-F
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.
- 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.
- It would be a plus if you also possess previous experience in:
- Knowledge of PQ, TMV, AQ, NPSV validations.
- Exposure to Gamp5 or similar regulations.
- ASQ Certified Quality Engineer (CQE).
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