Senior Quality Assurance Specialist

7 days ago


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

Entegee is seeking a skilled Associate Quality Systems Specialist to support engineering and quality system activities with a strong focus on medical device regulations.

As a key member of our team, you will ensure compliance with 21 CFR Part 820 - Quality System Regulation and contribute to maintaining and enhancing medical device quality management system standards (ISO 13485).

  • 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

What We Offer:

  • A competitive hourly rate of $30.00 to $35.00 per hour
  • A comprehensive benefits package, including medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits, and a 401K plan

Equal Opportunity Employer: Entegee is an equal opportunity employer and welcomes applications from qualified candidates with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements.



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