Staff Quality Assurance Engineer

About the role

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.

Responsibilities

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

Essential Requirements

• 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

Preferred Qualifications

• 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

Benefits

Beckman 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. Check out our benefits at Danaher Benefits Info.