Quality Specialist

• Manage day-to-day administration of the CAPA process
• Coordinate CAPA activities from initiation through closure
• Lead CAPA review meetings and track action item completion
• Coordinate investigations, root cause analyses, corrective and preventive actions, and effectiveness verification
• Develop CAPA metrics and trend analysis reports for Quality Management Reviews
• Coordinate product recalls, advisory notices, field actions, and other post-market actions
• Initiate, process, and drive Health Hazard Evaluation activities to completion
• Organize and lead the Device Safety Review Board
• Assist with recall strategies, risk assessments, customer notifications, and effectiveness checks
• Track field action progress and required activities
• Support regulatory reporting and documentation for recalls and advisory notices
• Conduct continuous improvement initiatives throughout the Quality Management System
• Support training related to CAPA, recalls, advisory notices, and quality system processes
• Provide front-room support and records for internal audits, external audits, MDSAP audits, and regulatory inspections
• Assist with audit responses and corrective action implementation
• Provide back-up support for complaint intake and complaint investigations
• Report to the VP of Operations, Customer Service & QARA
• Lead cross-functional teams during CAPA investigations, recalls, advisory notices, and field actions

Senior CAPA and Recall Specialist improving medical-device quality systems at IMRIS

Senior Quality Systems Specialist – CAPA & Recall

Senior CAPA and Recall Specialist coordinating corrective actions, recalls, and audits. Supporting IMRIS, a global intraoperative MRI and surgical-environment company, in regulatory compliance and QMS improvement.

• Lead and organize training for all Quality Specialists on audit processes, procedures, and tools.
• Conduct complex audits and verifying quality standards for selected inquiries and make decisions whether discrepant information meets BCBSA and FEP audit requirements, state, and federal mandates.
• Provide second-level support on escalated issues and audit findings.
• Collaborate with team members, OCLD, and management to identify training gaps and business needs and implement actions while partnering to address these issues.
• Review, evaluate, and provide feedback on trainees’ audits and learning processes.
• Act as a consultant with external departments to help resolve high-impact business issues by recommending action plans related to quality assurance.
• Assist the Data Reporting Analyst in collecting data and providing analyses for various issues across the department and other functional areas.
• Foster a training and auditing culture that values diversity of thought, leveraging team member strengths to achieve team goals.
• Assist with external audits and lead special projects.
• Perform other duties as assigned.

Quality Specialist III ensuring compliance and conducting complex audits at Premera.

Quality Specialist III

Quality Specialist III role at Premera focusing on compliance, quality assurance, and auditing within healthcare services.

• Ensures the quality assurance programs and policies are maintained and modified regularly.
• Facilitates uniform standards worldwide and enables best practice sharing, thereby fostering the achievement of company's mission globally.
• Develops, modifies , applies, and maintains quality standards and protocol for processing materials into partially finished or finished materials product .
• Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment .
• Ensures that corrective measures meet acceptable reliability standards, and that documentation is compliant with requirements .
• Provides Corrective and Preventive CAPA oversite and guidance.
• Develops employee communication and training programs that focus on the elements of a companywide CAPA and compliance program.

Sr Quality Systems Specialist handling CAPA processes in healthcare technology

Senior Quality Systems Specialist

Sr Quality Systems Specialist handling CAPA processes in healthcare technology. Ensuring compliance with regulations and providing guidance in quality assurance programs.

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Senior Quality Systems Specialist – CAPA & Recall

Quality Specialist III

Senior Quality Systems Specialist