Description
Quality Engineer - (Medical Device)
Location: 100% ONSITE - Hebron, Kentucky (41048)
Type: W2 contract (NO C2C OR THIRD PARTY)
Pay Rate: $40 - $45/hour
Duration: 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.
Responsibilities:
- 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, ISO13485, and other regulatory standards.
- Collaborate closely with cross-functional teams to support validation and quality initiatives.
Required Qualifications:
- 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.
Preferred Qualifications:
- Previous experience with PQ, TMV, AQ, NPSV validations.
- Exposure to Gamp5 or similar regulations.
- ASQ Certified Quality Engineer (CQE) certification.
Work Authorization: Must be currently located and authorized to work in the United States without sponsorship requirements. - No C2C or third-party candidates.~
*** Kelly does not expense relocation/interview costs. ***
Important information: To be immediately considered, please send an updated version of your resume to Deas172@kellyservices.com.
Apply today to join our Process Validation Group and contribute to high-impact quality initiatives.
As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.
Why Kelly® Engineering?
Your engineering skills are in demand, but how do you find the right fit? Easy. At Kelly Engineering, our team creates expert talent solutions to solve the world's most critical challenges. We connect you with leading organizations where you can collaborate on innovative projects, work with cutting-edge technologies and accelerate your growth. Whether you prefer the variety and flexibility of short-term projects or are looking for a long-term opportunity, we're here to guide you to the next step in your engineering career.About Kelly
Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.
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