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.
P...
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