Remote Senior Staff Software Quality Engineer

Location: Nationwide

Compensation: To Be Discussed

Staff Reviewed: Tue, Jul 19, 2022

This job expires in: 6 days

Job Category: Information Technology

Remote Level: 100% Remote

Weekly Hours: Full Time

Employer Type: Employer

Career Level: Experienced

Education Level: Bachelors

Job Summary

A biotechnology company has a current position open for a Remote Senior Staff Software Quality Engineer.

Core Responsibilities of this position include:

Leading software design control activities as a quality representative
Assessing compliance to established processes for development and release of software
Partnering with cross-functional teams to establish processes for 3rd party software onboarding

Qualifications Include:

BA/BS with 8+ years of Quality experience in a medical device environment
Advanced knowledge of medical device SDLC and Design Control processes
Applied experience related to FDA 21 CFR 820, ISO 13485, ISO 14971 and IEC 62304
Expert level experience in establishing and implementing processes for 21CFR Part 11 compliance
Experience with GAMP 5 as applicable, and familiar with Confluence, Jira, and Github
Direct experience with Agile development methodologies

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Remote Senior Staff Software Quality Engineer

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COMPLETE JOB DESCRIPTION

Company Overview

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