# Quality Assurance Specialist, Sr

Hiring organization: [A-dec](https://career.thegoodapps.co/organizations/a-dec)

Canonical page: https://career.thegoodapps.co/jobs/117e6e20-cc8c-44ad-9734-b19c1e5239bd

Listed on A-dec's own careers site. Applications go to them directly.

- Seniority: Senior
- Location: Newberg, OR

## Summary

This role manages quality management systems and regulatory compliance for a medical device manufacturer, ensuring adherence to FDA and international standards through internal audits, corrective action programs, and cross-functional coordination. It suits someone with quality assurance experience in regulated industries who is comfortable with compliance documentation and comfortable leading others.

_Our summary, not A-dec's wording._

## Skills named

ISO 13485, Microsoft Office, Project Management, Root Cause Analysis, Statistical Analysis

## Required

- Bachelor's degree in business, science, or engineering
- At least four years of QMS administrator experience
- Working knowledge of FDA, CMDR, EUMDR, ISO 13485, and MDSAP standards
- Proficiency in Microsoft Office
- Strong technical writing and communication skills
- Impeccable attention to detail and organizational skills

## Nice to have

- Experience as a lead internal auditor of Quality Management Systems
- Familiarity with enterprise quality management system (eQMS) software platforms

Apply on A-dec's site: https://adec.wd5.myworkdayjobs.com/en-US/A-dec/job/Oregon---Newberg-Campus/Quality-Assurance-Specialist--Sr_JR101956