Apply on Employer Site

Whip Mix Corporation · 4 hours ago

Quality Engineer

Louisville, KY

Full-time

Onsite

Senior Level

5+ years exp

Whip Mix Corporation is a family-owned company based in Louisville, known for its innovative solutions for dental professionals worldwide. They are seeking a Quality Engineer who will be instrumental in maintaining compliance, advancing product development, and ensuring regulatory readiness.

Health CareManufacturingMedicalMedical Device

H1B Sponsor Likely

Responsibilities

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

Qualification

ISO 13485QMS managementProcess validationCAPA activitiesRegulatory complianceAuditor certificationQE certificationStatistical data trendingRisk assessments

Required

Bachelor's degree in engineering or related field

Experience in process validation, CAPA activities and productions non-conformances required

Preferred

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

Company

Whip Mix Corporation

Whip Mix is a medical device company offering dental supplies and lab equipment.

Founded in 1919

Louisville, Kentucky, USA

51-200 employees

http://whipmix.com

H1B Sponsorship

Whip Mix Corporation has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2021 (1)

Funding

Current Stage

Growth Stage

Total Funding

$0.23M

2022-09-02Debt Financing· $0.23M

Leadership Team

Anne Steinbock

Chief Executive Officer

Scott Frasure

CFO

Company data provided by crunchbase