# Sr Quality Engineer

Hiring organization: [Medtronic](https://career.thegoodapps.co/organizations/medtronic)

Canonical page: https://career.thegoodapps.co/jobs/e03b9fb7-7d9a-40dc-a570-47ba2beb5245

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

- Seniority: Senior
- Location: Humacao, Puerto Rico, United States of America

## Summary

This role supports quality assurance in a regulated medical device manufacturing environment, managing investigations, compliance documentation, and continuous improvement across production processes. It suits engineers with healthcare manufacturing experience who are comfortable with FDA/ISO systems and can work cross-functionally to resolve quality issues.

_Our summary, not Medtronic's wording._

## Skills named

Corrective And Preventive Action (CAPA), Design of Experiments (DOE), Failure Mode and Effects Analysis (FMEA), ISO 13485, Lean Six Sigma, Microsoft Excel, Minitab, Power BI, Python, Risk Management, SAP, Statistical Process Control (SPC), VBA

## Required

- Bachelor's degree in engineering
- Minimum 4 years of relevant engineering, quality, or manufacturing experience (or Master's degree with 2 years experience, or PhD with 0 years experience)
- Quality systems knowledge
- Manufacturing process experience
- Technical documentation skills

## Nice to have

- Bachelor's or Master's degree in Mechanical, Industrial, or Electrical Engineering
- Medical device or FDA/ISO-regulated manufacturing experience
- Knowledge of GMP and inspection readiness
- Validation concepts (URS, SRS, IQ, OQ, PQ)
- NPI and product transfer support experience
- Machining, anodizing, packaging, or inspection process knowledge
- Structured problem-solving tools (5 Whys, Fishbone, FMEA, fault tree analysis)
- Statistical methods and SPC capability
- Minitab, JMP, Power BI, SAP, JDE, or Factory Works
- Lean Six Sigma Green Belt or Black Belt
- Automation and basic programming (VBA, Python)

Apply on Medtronic's site: https://medtronic.wd1.myworkdayjobs.com/en-US/MedtronicCareers/job/Humacao-Puerto-Rico-United-States-of-America/Sr-Quality-Engineer_R72446-1