Staff Quality Assurance

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Beckman Coulter Diagnostics, one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact.  You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life. As a global leader in clinical diagnostics, Beckman Coulter Diagnostics has challenged convention to elevate the diagnostic laboratory’s role in improving patient health for more than 90 years. Our diagnostic solutions are used in routine and complex clinical testing, and are used in hospitals, reference and research laboratories, and physician offices around the world. Every hour around the world, more than one million tests are run on Beckman Coulter Diagnostics systems, impacting 1.2 billion patients and more than three million clinicians per year. From uncovering the next clinical breakthrough, to rapid and reliable sample analysis, to more rigorous decision making—we are enabling clinicians to deliver the best possible care to their patients with improved efficiency, clinical confidence, adaptive collaboration, and accelerated intelligence. Learn about the Danaher Business System which makes everything possible. The Staff Quality Assurance provides quality assurance leadership to ensure the integrity of products manufactured, services provided to support business and customer needs, and comply with government regulations, industry and company standards. May develop, maintain, monitor, and audit quality management system and protocols including systems automation, processes, and procedures that ensure compliance with regulations and standards.  Will support and may lead audit and inspection preparation, resolution of audit and inspection findings. May be responsible for performance monitoring and will  have frequent interaction with other functional areas and operating entities including site leadership. This position reports directly to the Senior Manager Quality Assurance and is an on-site position at the Hebron, KY Reagent Manufacturing site and a critical part of a large multisite US operations quality organization.  In this role, you will have the opportunity to: Manager process and product non-conformances in line with company procedures and may review, investigate, resolve and report on quality discrepancies; support and act as quality assurance lead for product and process validations within the manufacturing site.  Partner with manufacturing professionals to provide QMS guidance and approvals for production deviations, nonconformances, and validation activities, including test method validation and IQ/OQ/PQ. Support—and, when needed, lead—audit and inspection readiness activities, including the resolution of resulting findings. Monitor performance and collaborate frequently with cross-functional teams, other operating companies, and site leadership to navigate moderate-complex issues within the quality system. The essential requirements of the job include: 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) Travel, Motor Vehicle Record & Physical/Environment Requirements: if applicable for role   Ability to travel – no more than 20%  Ability to lift, move or carry equipment up to 25lb, any other physical requirements  It would be a plus if you also possess previous