Senior Quality Assurance Engineer

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 Engineer for Beckman Coulter Diagnostics is responsible for the quality of Logistic and Distribution Processes for Hebron and the North American Region.

This position is part of the Logistics, Distribution and Transportation Quality Team located in Hebron, Kentucky as an on-site role. At Beckman Coulter, our vision is to relentlessly reimagine healthcare, one diagnosis at a time.

You will be a part of the Logistics and Distribution Quality team and report to the Quality Manager, Logistics & Distribution responsible for the Quality of Logistics, Distribution & Transportation of North America. If you thrive in a multifunctional role and want to work to build a world-class Logistics and Distribution organization—read on.

In this role, you will have the opportunity to:

• Lead Quality initiatives, with a focus on the North America Region and Hebron location, by providing direct operational support to L&D Operations by ensuring that quality is brought to every aspect of daily operations.

• Responsible for collaborating with the North America L&D Local Process Owners to ensure L&D compliance to applicable Quality System Standards and regulations. Partner with L&D Operations to create, review, improve and implement changes related to Quality System documentation through strong communication and change management practices.

• Participates with team in the use of Danaher Business System tools and activities including Daily Management, Problem Solving Process teams and Kaizen Events

• Support audit preparation, 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.

• Support the Global Process Owner for the global Quality System elements: Logistics, Distribution and Transportation, by partnering to maintain global policies, procedures, and work instructions to ensure compliance with local, state, and federal environmental regulations and standards. Includes compliance with FDA, Medical Device Single Audit Program (MDSAP), ISO13485, European Union Medical Device Directives (MDD), and In-Vitro Medical Device Regulation (IVDR) and applicable global regulatory requirements.

The essential requirements of the job include:

• Bachelor’s degree with 5+ years’ experience, or Master’s degree with 3+ years’ experience or Doctoral degree in field with 0+ years of experience

• Regulated environment quality experience or knowledge of FDA or ISO 9001

• 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:

• Experience of working within a global, multi-cultural, matrix organization

• Strong grasp of Trade Compliance, Material Regulations, INCO terms and their connection to Quality System Requirements

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We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform crucial job functions, and to receive other benefits and privileges of employment. Please contact us at [email protected] to request accommodation.