Quality Systems Specialist I

POSITION SUMMARY

ESSENTIAL JOB DUTIES AND RESPONSIBILITIES

• Demonstrates knowledge of applicable Centers for Medicare and Medicaid Services (CMS), Food and Drugs Administration (FDA), United Network for Organ Sharing (UNOS), Association of Organization Procurement Organizations (AOPO), American Association of Tissue Banks (AATB), and State of California requirements.
• Establishes and maintains controlled documents such as procedures and forms. 
• Ensures organ donor records and data reporting are in compliance with regulatory agencies, (e.g. AOPO, UNOS, CMS, CDC, AATB and FDA).
• Collects, analyzes, and trends performance-related data.
• Participates in internal and external audits.
• Prepares for regulatory audits such as the AOPO, CMS, UNOS, and AATB etc. 
• Coordinates and performs corrective action activities related to regulatory audits.
• Maintains accreditations, licensures, and registrations.
• Performs, tracks and reports occurrences, complaints, and corrective and preventive action (CAPA)
• Performs quality-related aspects of equipment and facility management including calibrations, qualifications, equipment files, record reviews, etc.
• Qualifies supplies, suppliers, and establishments that provide critical services.
• Performs or assists in validation of equipment, software, etc. 
• Maintains and monitors the training system/program to meet regulatory requirements. Assists with or performs training plan development, training plan changes, employee onboarding, and employee orientation. Monitors and reports on training compliance. 
• Participates in process and performance monitoring and improvement projects and training as directed by Quality Systems Management.
• Serves as the Quality representative on cross-functional and multi-site teams.
• Maintains confidentiality of all donor/recipient information.
• Reports workload and keep Quality Systems Management informed. 
• Ensures systems used in Quality Systems are properly maintained.

QUALIFICATIONS

• Completes job duties at direction of management with supervision as needed.
• Developing knowledge of applicable standards and regulations. May consult with management and rely on research to assure compliance in all aspect of their role.
• Contributes to selected departmental and cross-departmental projects/audits.

EDUCATION AND EXPERIENCE

• Associates degree in biological sciences or equivalent education/work experience in a structured regulated environment such as medical device or pharmaceuticals.
• Current California driver’s license and current vehicle insurance based on California minimum insurance coverage standards.
• Experience with organ and/or tissue donation and/or transplantation a plus.
• Working knowledge of medical terminology and medical record procedures a plus.