Staff Quality Assurance Engineer

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 Life Sciences, 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.

At Beckman Coulter Life Sciences, we know time is the most critical facet in the laboratory today:  time to get life-saving therapies to patients faster; reclaiming time by automating tedious manual workflows; and saving time spent addressing erroneous or complex results.

We are partners in time and accelerate answers to critical questions through the power of automation. We develop innovations for scientists by scientists, with many of our 3,300+ global colleagues coming from the laboratory.

It’s all part of our time-tested approach to bringing meaningful innovations at the speed of life since 1935. And we’re just beginning. Working together, let’s put our time and talents together to advance human health for tomorrow.

Learn about the Danaher Business System which makes everything possible.

The Staff Quality Assurance Engineer is responsible for owning quality related processes, guiding cross-functional teams through Beckman’s quality management system requirements, and ensuring product quality for Beckman’s customers. 

This position reports to the Senior Manager Manufacturing Quality and is part of the Quality & Regulatory Affairs organization located in Indianapolis, IN.  This will be an on-site role.  

In this role, you will have the opportunity to:

• Represent Quality Assurance on cross functional teams tasked with business critical initiatives ranging from quality improvement projects to new product transfers and launches.

• Apply your insight of current industry standards and regulations and how they relate to internal policies and procedures. Influence interpretation of internal policies and procedures to ensure quality and compliance.

• Serve as a local process owner and subject matter expert for Production & Process Controls as well as other manufacturing related QMS processes.

• Coach teams with application of ISO 9001/13485/cGMP and quality systems processes throughout product lifecycle

• Leverage data analytics and business intelligence tools to identify quality trends, monitor process performance, drive risk-based decision making, and communicate actionable insights to leadership

The essential requirements of the job include:

• Demonstrated experience supporting the manufacture of medical device instruments, electromechanical systems, laboratory instrumentation, diagnostic analyzers, automation platforms, or similar complex medical devices.

• Proven experience applying quality and regulatory requirements to manufacturing processes, process validation, equipment qualification, nonconformance management, CAPA, risk management, and continuous improvement activities.

• Working knowledge of ISO 9001 & ISO 13485 standards, and 21 CFR Part 820 & EU MDR/IVDR regulations

• Bachelor’s Degree (minimum) in engineering or other science or related field; or equivalent experience required.

• 7+ years' experience (or 4+ years with Master's Degree) in Quality Engineering, Manufacturing Engineering, or Quality Systems within regulated industries.

Travel, Motor Vehicle Record & Physical/Environment Requirements:

• Travel requirements < 20% of the time, domestic and international

• Overnight travel may be required

• Be able to occasionally lift and/or move up to 40 pounds.

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

• Advanced Power BI (or similar) capabilities including data modeling, DAX development, Power Query, dashboard design, KPI development, and integration of data from ERP, eQMS, manufacturing, and other enterprise systems

• Quality Engineering tools such as Six Sigma, DMAIC, Statistical Process Control, 5 why’s, 8D, PFMEA, Design of Experiment, etc.

• Oracle as an ERP and IQVIA as an eQMS

Beckman Coulter Life Sci