Sr Quality Assurance/Audit Engineer, Hebron Ky- Relocation Available

Wondering what’s within Beckman Coulter Diagnostics? Take a closer look.

At first glance, you’ll see that for more than 80 years we’ve been dedicated to advancing and optimizing the laboratory to move science and healthcare forward. Join a team where you can be heard, be supported, and always be yourself. We’re building a culture that celebrates backgrounds, experiences, and perspectives of all our associates. Look again and you’ll see we are invested in you, providing the opportunity to build a meaningful career, be creative, and try new things with the support you need to be successful.

Beckman Coulter Diagnostics is proud to work alongside a community of six fellow Diagnostics Companies at Danaher. Together, we’re working at the pace of change to improve patient lives with diagnostic tools that address the world’s biggest health challenges!

The Senior Quality Assurance/Audit Engineer for Beckman Coulter Diagnostics is responsible for the quality of the Logistics and Distribution Process for Hebron and the North America Region.

This position is part of the Logistics and Distribution Quality Team located in Hebron and will be a hybrid role the Hebron, KY Logistics and Distribution Quality Team.

You will be a part of the Hebron Logistics and Distribution Quality Team and report to the Quality Manager. If you thrive in a fantastic cross-functional team and want to work to build a world-class Quality Logistics and Distribution organization—read on!

In this role, you will have the opportunity to:

• Support audit preparation, and resolution of audit and inspection findings and liaises with auditing groups and inspectors throughout all stages of the audits. Own specific actions and develop Subject Matter expertise in defined areas of the Quality Management System.
• Lead Quality initiatives, with a focus on the North America Region and Hebron location, by providing direct operational support by ensuring that quality is brought to every aspect of daily operations.
• Execute activities to help educate and re-enforce Quality expectations through strong partnerships with associates and leaders through mock-audit actions.
• Mentor new or non-quality associates on the importance of Quality.

• Lead a Global CAPA Review Board for Logistics and Distribution related activities.
• Partner with L&D Operations to create, review, improve and implement changes related to Quality System documentation through strong communication and change management practices.
• Identify risk, develop mitigation strategies, alternative solutions, resolve issues, etc. in collaboration with cross-functional groups.
• Participates with the team in the use of Danaher Business System tools and activities including Daily Management, Problem Solving Process teams and Kaizen Events
• Ensures the quality management system requirements are effectively established and maintained, in a state of compliance and inspection readiness
• Responsible for collaborating with the North America L&D Local Process Owners to ensure L&D compliance to applicable Quality System Standards and regulations.

The essential requirements of the job include:

• Experience with site audit planning and readiness for internal and external audits
• Regulated environment quality experience or knowledge of FDA QSR and ISO 13485
• Bachelor’s degree with 5+ years’ experience, or Master’s degree with 3+ years’ experience, or Doctoral degree with 0+ years of experience
• Proven fast learner, adept with new processes and software systems
• Exposure to CAPA including corrective action/preventive action process to improve quality
• Proficient in Microsoft Office (Outlook, Excel, Word)

It would be a plus if you also possess previous experience in:

• Knowledge of Medical Device Single Audit Program (MDSAP)

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When you join us, you’ll also be joining Danaher’s global organization, where 80,000 people wake up every day determined to help our customers win. As an associate, you’ll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful Danaher Business System tools and the stability of a tested organization.