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Associate Quality Systems Specialist
$62,400 - $72,800/Yr
Entegee - North Haven, CT
posted about 2 months ago
Full-time - Entry Level
North Haven, CT
Professional, Scientific, and Technical Services
About the position
The Associate Quality Systems Specialist supports engineering and quality system activities, ensuring compliance with medical device regulations and quality management processes. This role involves working with quality systems and risk management in the medical device industry, utilizing tools like JIRA for project management.
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)
Benefits
- Medical insurance
- Dental insurance
- Vision insurance
- Life insurance
- Short-term disability
- Additional voluntary benefits
- EAP program
- Commuter benefits
- 401K plan
- Paid Sick Leave
- Holiday pay
