Engineer - Quality Assurance (Expert Level)
Hebron, Kentucky, United States of America
Contract
1 week ago
$45 - $48 USD
Key skills
AI
About this role
Immediate need for a talented Engineer - Quality Assurance (Expert Level). This is a 12+ Months contract opportunity with long-term potential and location in Hebron, KY (Onsite). Please review the job description below and contact me ASAP if you are interested.
Job Diva ID: 26-15227
Pay rate: $45.00 - $48.00/hr. Employee benefits include, but are not limited to, health insurance (medical, dental, vision), 401(k) plan, and paid sick leave (depending on work location).
Key Responsibilities:
- Work Module: Monday to Friday (Standard working hours)
- 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.
Key Requirements and Technology Experience:
- 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.
- Knowledge of PQ, TMV, AQ, NPSV validations.
- Exposure to Gamp5 or similar regulations.
- ASQ Certified Quality Engineer (CQE).
Our client is a leading Medical Device/Diagnostics Industry, and we are currently interviewing to fill this and other similar contract positions. If you are interested in this position, please apply online for immediate consideration.
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