Quality Engineer

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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