Staff Quality Assurance (Diagnostics)

Location: On-site at the Hebron, Kentucky, United States reagent manufacturing site

Company

Beckman Coulter Diagnostics is a hirify.global operating company developing clinical diagnostic solutions for hospitals, reference and research laboratories, and physician offices.

What you will do

• Provide quality assurance leadership for manufactured products, services, and quality management systems.
• Manage product and process nonconformances, including review, investigation, resolution, and reporting.
• Partner with manufacturing teams on QMS guidance, approvals, deviations, nonconformances, and validation activities.
• Lead or support product, process, and test method validation, including IQ/OQ/PQ activities.
• Support audit and inspection readiness and resolve resulting findings.
• Monitor quality performance and collaborate with cross-functional teams, operating companies, and site leadership on complex quality-system issues.

Requirements

• Bachelor’s degree with 8+ years of experience, master’s degree with 6+ years, or doctoral degree with 3+ years.
• Ability to articulate the impact of nonconformances on product quality.
• Ability to influence without direct authority and communicate complex, high-impact quality issues to leadership.
• Familiarity with test method science and validation principles, including IQ/OQ/PQ.
• Ability to travel up to 20% and lift, move, or carry equipment weighing up to 25 lb.

Nice to have

• ASQ or accredited quality and engineering certification.

Culture & Benefits

• Access to comprehensive healthcare programs and paid time off.
• Work within hirify.global’s continuous improvement system and a multisite US operations quality organization.
• Collaborate with teams across operating companies and clinical diagnostics operations.