# Staff Quality Assurance Engineer

Hiring organization: [Beckman Coulter](https://career.thegoodapps.co/organizations/beckman-coulter)

Canonical page: https://career.thegoodapps.co/jobs/6b391c8d-fe36-4459-8d6b-a4514d8b9d77

Listed on Beckman Coulter's own careers site. Applications go to them directly.

- Employment type: full time
- Seniority: Senior
- Location: Indianapolis, IN

## Summary

This role leads quality assurance processes for medical device manufacturing at a major diagnostics company, managing compliance with regulatory standards and guiding teams through the quality lifecycle. It suits experienced quality engineers who want to influence manufacturing operations and drive process improvements in a regulated industry.

_Our summary, not Beckman Coulter's wording._

## Skills named

ISO 13485, ISO 9001, Power BI, Six Sigma, Statistical Process Control (SPC)

## Required

- Experience with medical device manufacturing (instruments, electromechanical systems, laboratory instrumentation, diagnostic analyzers, or automation platforms)
- Quality and regulatory requirements applied to manufacturing processes, process validation, equipment qualification, nonconformance management, CAPA, and risk management
- ISO 9001 and ISO 13485 working knowledge
- 21 CFR Part 820 and EU MDR/IVDR working knowledge
- Bachelor's degree in engineering, science, or related field (or equivalent experience)
- 7+ years in Quality Engineering, Manufacturing Engineering, or Quality Systems in regulated industries (or 4+ years with Master's degree)
- On-site work in Indianapolis, IN

## Nice to have

- Power BI advanced capabilities (data modeling, DAX, Power Query, dashboard design, KPI development)
- Quality engineering tools (Six Sigma, DMAIC, Statistical Process Control, 5 whys, 8D, PFMEA, Design of Experiment)
- Oracle ERP experience
- IQVIA eQMS experience

Apply on Beckman Coulter's site: https://danaher.wd1.myworkdayjobs.com/en-US/DanaherJobs/job/Indianapolis-Indiana-United-States/Staff-Quality-Assurance-Engineer_R1314639