Staff Quality Assurance Engineer

Staff Quality Assurance EngineerAre 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.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.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 lifecycleLeverage data analytics and business intelligence tools to identify quality trends, monitor process performance, drive risk-based decision making, and communicate actionable insights to leadershipThe 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 regulationsBachelor'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 internationalOvernight travel may be requiredBe 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 systemsQuality 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 eQMSBeckman Coulter Life Sciences, 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.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.Danaher Corporation and all Danaher Companies are committed to equal opportunity regardless of race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender identity, or other characteristics protected by law.