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Remote Senior Staff Software Quality Engineer

Job is Expired
Location: Nationwide
Compensation: To Be Discussed
Staff Reviewed: Tue, Jul 19, 2022
Job Category: Information Technology
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

COMPLETE JOB DESCRIPTION

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