Job Title: Quality Assurance Engineer
Job Location: Hebron, KY
Job Duration: 12 months
Pay rate: $44.05/hr on w2
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.
The essential requirements of the job include:
- 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.
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).