Senior Quality Assurance Lead — Life Sciences Diagnostics

Beckman Coulter Diagnostics; Hebron Estates (KY); On-site; USD 85,000 - 110,000; Full time

Job summary

Beckman Coulter Diagnostics, a Danaher operating company, seeks a Staff Quality Assurance professional for our Hebron, KY reagent manufacturing site. You will provide QA leadership to ensure product quality and regulatory compliance across a multisite organization, interfacing with cross-functional teams to uphold high standards.

The role emphasizes non-conformance management, process validations, and audit readiness, with travel up to 20%.

Qualifications

• Bachelor’s degree with 8+ years of work experience OR Master’s degree with 6+ years of work experience OR Doctoral degree with 3+ years of work experience.
• Articulate the risk impact of nonconformances on product quality.
• Ability to influence without direct authority and communicate complex/large impact product quality issues in a leadership setting.
• Familiarity with test method science and validation principles (IQ/OQ/PQ).

Responsibilities

• Manage process and product non-conformances and lead QA for product and process validations within the site.
• Provide QMS guidance and approvals for production deviations, nonconformances, and validation activities, including IQ/OQ/PQ.
• Support audit and inspection readiness activities and resolve findings.
• Monitor performance and collaborate with cross-functional teams and site leadership to address moderate-complex quality issues.

Skills

Quality assurance

Regulatory compliance

Leadership

Education

Bachelor’s degree

Master’s degree

Doctoral degree

Tools

IQ/OQ/PQ

Job description

Beckman Coulter Diagnostics, a Danaher operating company, seeks a Staff Quality Assurance professional for our Hebron, KY reagent manufacturing site. You will provide QA leadership to ensure product quality and regulatory compliance across a multisite organization, interfacing with cross-functional teams to uphold high standards.

The role emphasizes non-conformance management, process validations, and audit readiness, with travel up to 20%.