Quality Engineer

Louisville, KY, United States of America

At Whip Mix, innovation isn’t just what we do—it’s who we are. For over a century, we’ve been a trusted partner to dental professionals worldwide. From designing and manufacturing cutting‑edge digital solutions to tried‑and‑true lab essentials, we bring craftsmanship, technology, and customer care together in one place.

We’re proud to be a family‑owned, Louisville‑based company with a global reach, serving dental labs, universities, and clinicians across more than 80 countries. Our mission? To combine quality and creativity with a service‑first mindset that makes a real difference in people’s lives. If you’re looking to join a team where tradition meets innovation, and where every day brings new opportunities to grow, Whip Mix is the place for you.

We are looking for a Quality Engineer to join our team! You'll play a key role in maintaining compliance, advancing product development, and ensuring regulatory readiness.

What you'll be doing:

• Partner with product design and development teams to ensure products are safe, effective, and customer focused.
• Create and maintain Design & Development documentation in alignment with ISO 13485, cGMP, MDR, and MDSAP standards.
• Design, validate, and monitor manufacturing processes for medical and non‑medical products.
• Coordinate 510(k) submissions, CE Mark applications, and ensure technical documentation meets ISO and regulatory standards.
• Lead external quality audits (FDA, ISO, customer) and prepare compliance documentation.
• Perform risk assessments, capability analyses, and statistical data trending to validate designs and processes.
• Support root cause investigations, corrective/preventive actions (CAPAs), and quality improvement initiatives.
• Develop quality plans for incoming and outsourced materials/products.

What you'll bring to the table:

• Bachelor's degree in engineering or related field
• Advanced training related to QMS disciplines
• Auditor and QE certifications are preferred
• 5+ years of experience managing/developing a QMS that meets FDA and ISO 13485 requirements preferred
• Experience in process validation, CAPA activities and productions non‑conformances required

Benefits:
Medical Insurance, Life Insurance, Dental Insurance, Vision Insurance, Paid Vacation, Paid Sick Days, Paid Holidays