1. Quality Process Expertise:
• Perform all responsibilities of the Quality Associate.
• Serve as a Subject Matter Expert (SME) in one or more Quality processes such as incoming inspection, change management, and/or records, including batch release.
2. Records Administration and Batch Record Review:
• Support record administration and batch record review processes.
• Create Certificates of Analysis (CoA) and Certificates of Conformance (CoC) for material lot releases.
3. Change Management:
• Assign labeling and pre-production change requests to Change Management staff based on experience, project load, and complexity.
• Process Investigational Use Only (IUO) and In Vitro Diagnostic (IVD) product labeling and associated RMS change requests while ensuring compliance with company policies.
• Navigate complex changes, troubleshoot issues, and support junior staff in creating design change plans.
4. Change Packet Analysis and DMR Maintenance:
• Support the review and processing of change packets in accordance with approved procedures.
• Analyze change packets for impacts on Device Master Records (DMRs) and ensure proper maintenance of DMRs.
• Proactively identify and correct issues, providing collaborative support to improve future submissions.
5. Design History File (DHF) Management:
• Create and maintain Design History Files (DHFs) per approved procedures.
• Review DHFs for documentation practices and compliance with Document Change Control requirements.
• Maintain the Master Action Item List, DHF Index, and DHF History Index.
6. Process Documentation and Continuous Improvement:
• Assist in documenting key processes and departmental procedures.
• Participate in and lead continuous improvement projects as assigned.
7. Metrics and Reporting:
• Compile and maintain data for departmental metrics and reports.
• Own key local reporting responsibilities and take the lead in areas of expertise.

• Education and Experience:
• Bachelor’s degree in a related field preferred or equivalent professional experience.
• A minimum of 3-5 years in quality assurance, change management, or related roles.
• Skills and Competencies:
• Strong knowledge of quality systems, including change management, batch release, and DHF maintenance.
• Ability to navigate complex processes and troubleshoot issues effectively.
• Excellent organizational skills with attention to detail and accuracy.

Pay Range: $30/hr - $32/hr.