Senior Quality Assurance Engineer

Position Overview

The Senior Quality Assurance Engineer is responsible for owning quality related processes in an instrument manufacturing environment, 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.

• 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 manufacturing best practices, and how they relate to internal policies and procedures. Influence interpretation of internal policies and procedures to ensure quality and compliance.
• Monitoring and analyzing quality performance:
  First-Pass Yield (FPY), Defect Per Unit (DPU), Complaints and other necessary Quality metrics to ensure high product quality and process improvement opportunities are identified.
• Work closely with Manufacturing, Manufacturing Engineering, Development, Technical Support, and Suppliers to identify improvement opportunities and drive problem solving activities using quality engineering tools.

• 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.
• 5+ years’ experience (or 3+ with Master’s Degree) in engineering, manufacturing and/or quality systems (ISO 9001), medical device (ISO 13485), pharmaceutical, related life sciences or other regulated industries.
• Effective leadership, communication, interpersonal, and problem-solving skills.

• Travel requirements < 10% of the time, domestic and international.
• Overnight travel may be required.
• Be able to occasionally lift and/or move up to 40 pounds.

• Process Validations, either through development of validation strategies, plans, & protocols or execution and reporting.
• 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 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.

The U.S. EEO posters are available here. We comply with federal and state disability laws and make reasonable accommodations for applicants and employees with disabilities. If reasonable accommodation is needed to participate in the job application or interview process, to perform essential job functions, and/or to receive other benefits and privileges of employment, please contact: or