Sr Quality Engineer 1
Location: Portland
Category: Other Area(s)
Employment Type: Contract
Work Location: On-Site
Job ID: 36172
Date Added: 05/15/2026
Quality Senior Engineer I
Onsite in Englewood, CO
Summary
We’re looking for a Quality Senior Engineer I to support CAPA remediation, quality system compliance, and documentation efforts within a regulated medical device environment. This role will focus heavily on reviewing and improving CAPA records, supporting investigations, and ensuring compliance with FDA and ISO quality standards.
Responsibilities
- Review, remediate, and migrate CAPA records into EtQ
- Manage CAPAs through investigation, tracking, verification, and closure
- Perform gap assessments and correct documentation deficiencies
- Partner cross-functionally with Quality, Regulatory, Operations, and Engineering teams
- Support compliance with CAPA procedures, documentation standards, and quality system requirements
- Assist with training and guidance related to CAPA and EtQ processes
Qualifications
- 3–5 years of experience in a Quality Engineering role
- Strong experience with CAPA processes and root cause investigations
- Experience with eQMS systems (EtQ preferred)
- Knowledge of FDA QSR (21 CFR Part 820), ISO 13485, and ISO 14971
- Experience with risk management, FMEA, and quality documentation
- Medical device industry experience preferred, especially orthopedic manufacturing
- Strong communication, technical writing, and organizational skills
Mainz Brady Group is a technology staffing firm with offices in California, Oregon, Washington and Texas. We specialize in Information Technology and Engineering placements on a Contract, Contract-to-hire and Direct Hire basis. Mainz Brady Group is the recipient of multiple annual Excellence Awards from the Techserve Alliance, the leading association for IT and engineering staffing firms in the U.S. Mainz Brady Group is an Equal Opportunity Employer. We are committed to Diversity & Inclusion and incorporate non-discrimination best practices in all our staffing processes. Mainz Brady Group does not discriminate based on race, color, religion, sex, sexual orientation, gender identity, gender expression, age, disability or any other protected class.
