# Senior Quality Assurance Engineer

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

Canonical page: https://career.thegoodapps.co/jobs/767751c6-20d9-401b-a356-4fafea666aef

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

- Employment type: full time
- Seniority: Senior
- Salary: 116000 – 159500 USD per year

## Summary

This role develops quality systems and manages compliance for medical device manufacturing, ensuring products meet regulatory standards through design controls, risk assessment, and process validation. It suits experienced quality engineers who want to drive innovation in life sciences diagnostics while working on high-impact healthcare solutions.

_Our summary, not Beckman Coulter's wording._

## Skills named

Failure Mode and Effects Analysis (FMEA), Good Manufacturing Practice (GMP), ISO 13485, Risk Management

## Required

- BS in mechanical, industrial, biomedical engineering or related field with 5+ years quality engineering experience, or MS with 3+ years quality experience
- Understanding of ISO 13485, 21 CFR 820, and GMP requirements
- Experience with NPI quality and complex systems including design verification/validation, part and process qualification, and equipment qualification
- Domestic and international travel up to 10%

## Nice to have

- Medical device or pharmaceutical manufacturing experience
- Certified Quality Engineer certification
- Lead Auditor certification

Apply on Beckman Coulter's site: https://danaher.wd1.myworkdayjobs.com/en-US/DanaherJobs/job/Sunnyvale-California-United-States/Senior-Quality-Assurance-Engineer_R1314807