Quality Engineer Medical Device

Pay Rate

$40 - $45/hour

12-month contract (Estimated to end 3/30/27; contract extension potential)

We are seeking an experienced Quality Engineer for a 12-month W2 contract at our medical device manufacturing facility in Hebron, KY. The Quality Assurance Engineer will be a key member of the Process Validation Group, reporting to the Senior Manager, Process Validation.

• Write and conduct IOQ and spreadsheet validations.
• Complete PQ, TMV, and AQ validations.
• Develop, maintain, monitor, and audit quality management systems and protocols—including systems automation, processes, and procedures—to ensure compliance with CFR 21 Part 820, ISO
  13485, and other regulatory standards.
• Collaborate closely with cross-functional teams to support validation and quality initiatives.

• Bachelor’s degree in engineering (mechanical, electrical, chemical, bioengineering, or related area).
• At least 5 years of experience in the medical device industry.
• Strong proficiency in Microsoft Excel and computer programming/systems.

• Previous experience with PQ, TMV, AQ, NPSV validations.
• Exposure to Gamp5 or similar regulations.
• ASQ Certified Quality Engineer (CQE) certification.

Must be currently located and authorized to work in the United States without sponsorship requirements.
No C2C or third-party candidates.

To be immediately considered, please send an updated version of your resume to

Apply today to join our Process Validation Group and contribute to high-impact quality initiatives.