Quality Systems Specialist II

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) 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, 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 (QS) are properly maintained.

QUALIFICATIONS

• Regularly and directly assists quality management team under only general supervision.
• Uses working knowledge of applicable standards and regulations to make independent choices to assure compliance in all aspect of their role.
• Experience performing/mastery of more than half of essential job duties and responsibilities.
• Makes recommendations for quality assurance and performance improvement initiatives.
• Serves as lead on selected departmental projects/audits and as a participating member of cross-departmental projects.
• Trains QS department and all DNWest’s staff on selected QS and Performance Improvement topics related to areas of expertise.

EDUCATION AND EXPERIENCE

• Bachelor’s degree in a life science or equivalent education/work experience in a structured regulated environment such as biologics, 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 preferred.
• Working knowledge of medical terminology and medical record procedures preferred.
• Quality certification in a relevant quality discipline such as Certified Quality Auditor, Lean Certification a plus.
• Certified Tissue Bank Specialist (CTBS), Certified Procurement Transplant Coordinator (CPTC), Certified Eye Bank Technician (CEBT) certifications preferred.