ApplyBlast uses AI to match you with the right jobs, tailor your resume and cover letter, and apply automatically so you can land your dream job faster.

Features

Auto Apply Resume Optimizer Cover Letter Optimizer Interview Prep

Company

Social Media

Need Help?

team@applyblast.com

Staff Software Quality Engineer at iRhythm - ApplyBlast

Staff Software Quality Engineer

iRhythm

5 months ago

2.9 on Glassdoor

Orange County, CA

Hybrid

Full Time

Senior

0 applicants

View Job Listing

Apply to 100+ jobs

About this role

The Staff Software Quality Engineer serves as the technical lead and subject matter expert for the strategy, validation, and compliance of non-product software used in medical device manufacturing and processing. This role ensures all applications supporting GxP business processes and development tools are validated according to FDA and ISO standards while collaborating with cross-functional teams to maintain audit readiness.

Responsibilities

Define and lead Computer Software Assurance strategies and validation master plans
Apply risk-based testing methodologies to determine validation rigor for manufacturing tools
Ensure compliance with 21 CFR Part 11 and ISO 13485 standards for all NPS activities
Review and approve validation protocols and software V&V reports
Lead qualification of software-based test and manufacturing equipment

Skills

Qualifications

BS in Computer ScienceBS in Biomedical EngineeringMaster's degree

About iRhythm

irhythmtech.com

Headquarters

San Francisco, California, United States

Company Size

1001-5000 employees

Founded

2006

View Profile

Discover the iRhythm monitoring service, featuring Zio® ECG monitors. Our monitoring solutions capture heartbeat data to help doctors detect cardiac arrhythmias.