What are the responsibilities and job description for the Quality Engineer position at The Fountain Group?
Quality Engineer
Pay: $40-$46/hr
Duration: 12-month contract with potential to extend or convert based on performance and budget.
100% Onsite in Hebron, KY
Responsible for, but not limited 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.
Requirements:
- Bachelor’s degree in engineering (mechanical, electrical, chemical, bioengineering, or a related area) is required.
- 5 years of experience in the medical device industry is required.
- Familiarity with CFR 21 Part 820 and ISO13485.
- Proficiency in Microsoft Excel and a good working knowledge of computer programming and systems is required.
- Knowledge of PQ, TMV, AQ, NPSV validations is preferred but not required.
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Salary : $40 - $46