Automation Controls Specialist

1 week ago


North Haven, Connecticut, United States Entegee Full time
Job Overview

We specialize in custom automation projects and are a major player in the world of controls and robotic solutions globally.

Salary Information

$33.50 - $38.50 per hour

Job Description

Key Responsibilities:

  • Support engineering tasks within medical device quality systems
  • Ensure compliance with 21 CFR Part 820 Quality System Regulation
  • Utilize JIRA and Atlassian products for project management tasks

Additional Responsibilities:

  • 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
Required Skills and Qualifications

Qualifications:

  • BS in Engineering (Electrical Engineering preferred)
  • 1-2+ years of relevant experience

Certifications and Knowledge:

  • 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)
Benefits

Benefit Offerings:

  • Medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits, and a 401K plan
Equal Employment Opportunity

We consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements.



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