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 experience in:- ASQ or accredited certifications in Quality and or engineering preferred.
Beckman Coulter Diagnostics, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info.
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Join our winning team today. Together, we'll accelerate the real-life impact of tomorrow's science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.
For more information, visit www.danaher.com.
