# Quality Assurance Specialist II

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

Canonical page: https://career.thegoodapps.co/jobs/981b028c-ad1a-47f5-882b-38130bec4006

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

- Employment type: full time
- Seniority: Mid
- Location: Fajardo, Puerto Rico

## Summary

This Quality Assurance role supports manufacturing operations in regulated life sciences, handling complaint investigations, nonconformance assessments, and continuous improvement at a Cytiva filtration and diagnostics facility. It suits someone with 5-10 years of pharma or medical device quality experience who wants hands-on involvement in investigations and process improvement in a compliant manufacturing environment.

_Our summary, not Beckman Coulter's wording._

## Skills named

Change Control, Corrective And Preventive Action (CAPA), Data Analysis, Risk Assessment, Root Cause Analysis

## Required

- Bachelor's degree in Biology, Microbiology, Engineering, or related scientific/technical discipline
- 5-10 years experience in regulated life sciences, medical device, pharmaceutical, biotechnology, or manufacturing
- Experience with cleanroom or controlled environment operations
- Experience leading or supporting quality investigations, complaints, nonconformances, root cause analysis, CAPA, risk assessments, or change control
- Proficiency with electronic quality systems and digital tools

## Nice to have

- Danaher Business System (DBS), Lean Six Sigma, or Toyota Lean System experience
- Cleanroom Management and Controlled Environments certification or background
- Life sciences, pharmaceuticals, or medical devices sector experience
- Valid driver's license with acceptable driving record
- Ability to travel up to 2%
- Ability to lift equipment up to 10 lbs

Apply on Beckman Coulter's site: https://danaher.wd1.myworkdayjobs.com/en-US/DanaherJobs/job/Fajardo-Puerto-Rico/Quality-Assurance-Specialist-II_R1308902