Senior Quality Assurance Specialist
7 days ago
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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