Overview
Quality Assurance Engineer Process Validation in Hebron, KY Jobs in Hebron, KY at Select Source International
Title: Quality Assurance Engineer Process Validation in Hebron, KY
Company: Select Source International
Location: Hebron, KY
Job Title Quality Assurance Engineer (Process Validation Expert Level)
Job Location Type In Person
Location Hebron, KY 41048
Job Type 12-Month Contract (Possible Temp-to-Hire)
Shift Schedule 1st Shift | Standard Business Hours
About The Role
We are seeking an experienced Quality Assurance Engineer to join the Process Validation (PV) team supporting reagent manufacturing operations.
This role is ideal for a validation-focused QA professional with strong experience in process validation, quality systems, and regulatory compliance within the medical device industry. You will play a key role in ensuring validation deliverables and quality systems meet stringent regulatory standards while supporting manufacturing and process improvements.
Key Responsibilities
Author and execute validation activities including:
IOQ (Installation, Operational, Qualification)Spreadsheet validation
PQ (Performance Qualification)
TMV (Test Method Validation)
AQ (Analytical Qualification)
Develop, maintain, and audit Quality Management System (QMS) processes and documentation
Monitor validation protocols and ensure compliance with internal and external standards
Support automation validation and system/process validation activities
Collaborate with senior QA staff and cross-functional teams within manufacturing and engineering
Ensure Compliance With
FDA regulations (21 CFR Part 820)
ISO 13485 standards
Identify gaps and drive continuous improvement in validation and quality processes
Required Qualifications
Bachelor s degree in Engineering (Mechanical, Electrical, Chemical, Bioengineering, or related field)
5+ years of experience in the medical device industry
Strong Hands-on Experience With
Process validation
Validation protocol development and execution
Working Knowledge Of
21 CFR Part 820
ISO 13485
Proficiency in Microsoft Excel
Basic understanding of computer systems, programming, or system validation
Preferred Qualifications
Experience with:
PQ, TMV, AQ, NPSV validations
Familiarity with GAMP 5 or similar computerized system validation frameworks
ASQ Certified Quality Engineer (CQE) certification
Experience supporting reagent manufacturing or similar regulated production environments
