Automation Quality Assurance Engineer

3 weeks ago


North Haven, Connecticut, United States Entegee Full time
About the Role

We are seeking an experienced Automation Quality Assurance Engineer to join our team. In this role, you will support engineering tasks within the framework of medical device quality systems and ensure compliance with 21 CFR Part 820 Quality System Regulation.

Key Responsibilities
  • Support engineering tasks within the framework of medical device quality systems
  • Ensure compliance with 21 CFR Part 820 Quality System Regulation
  • Utilize JIRA and Atlassian products for project and quality management tasks
  • Contribute to maintaining and enhancing medical device quality management system standards (ISO 13485)
  • Implement and support risk management processes in accordance with ISO 14971 requirements
Requirements
  • BS in Engineering (Electrical Engineering preferred)
  • 1-2+ years of relevant experience
  • Knowledge of 21 CFR Part 820 - Quality System Regulation
  • Familiarity with Atlassian products, specifically JIRA
  • Knowledge or experience with Medical Device Quality Systems (ISO 13485)
  • Understanding of Risk Management requirements (ISO 14971)
Compensation and Benefits

The estimated salary range for this position is $30-$35 per hour. Our company offers a comprehensive benefits package, including medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits, and a 401K plan.

About Us

We specialize in custom automation projects and are a major player in the world of controls and robotic solutions around the world. We are committed to helping our employees grow and develop their skills, with opportunities for professional growth and advancement.



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