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Quality Assurance Analyst II
2 months ago
Position Title: Quality Assurance Analyst II
Location: Des Plaines, Illinois
Contract Duration: 12 Months with potential for extension
Working Hours: 8:00 AM - 5:00 PM
Compensation: $30/hour on W2 without benefits
Role Responsibilities:- Possess comprehensive knowledge and ability to execute all duties associated with the Quality Associate role.
- Act as a Subject Matter Expert in specific Quality processes, including but not limited to incoming inspections, change management, and records management (including batch release).
- Provide support for record administration and batch record evaluations, which includes the creation of Certificates of Analysis and Certificates of Conformance for material lot releases.
- Delegate labeling and pre-production change requests to Change Management personnel, ensuring alignment with project demands and complexity.
- Process product labeling for IUO and IVD, along with the corresponding RMS change requests, while ensuring adherence to company policies and protocols.
- Demonstrate the ability to navigate complex scenarios and resolve issues related to intricate changes.
- Assist labeling change owners and junior personnel in formulating design change plans.
- Utilize subject matter expertise to positively influence organizational outcomes.
- Support the preparation of change packets according to approved procedures, including the analysis of change packets for their impact on Device Master Records and the maintenance of DMRs.
- Independently rectify issues and proactively identify potential future challenges.
- Leverage expertise to enhance future submissions through collaboration with change owners.
- Establish and maintain Design History Files in accordance with approved procedures.
- Review documentation to ensure compliance with DHF documentation practices and adherence to Document Change Control requirements.
- Maintain the Master Action Item List, DHF Index, and DHF History Index.
- Contribute to the documentation of essential processes and departmental procedures, as well as participate in assigned continuous improvement initiatives.
Compile and manage data utilized for the development of departmental metrics and reports. Take ownership of key local reporting responsibilities and lead in areas of expertise as necessary.
Company OverviewSelect Source International (SSI) is a consulting firm specializing in IT, Health Care, and Engineering Services, established in 1998. Our consultants have consistently delivered exceptional services, earning appreciation from clients, customers, and users across various Fortune 500 companies, mid-sized enterprises, and consulting firms.
