At Vitalant, we’re driven by a mission to save lives through blood and biomedical services—and every role plays a part in that impact. We’re currently seeking a Information Systems Quality Manager. In this role, you’ll help ensure the integrity and compliance of computerized medical devices and software systems across Vitalant and our business units. As a key subject matter expert, you’ll support both our Information Technology and Operations teams in maintaining the highest standards of quality and regulatory compliance—contributing to the safe and reliable systems that support our life-saving work.
Work location: This position will have a hybrid work environment operating from the Scottsdale, AZ location 3 days per week and working from a remote/ at-home office 2 days per week.
As an Information Systems Quality Manager Contractor, you'll get to:
Provide quality oversight and guidance on IT change control documents, ensuring regulatory compliance before implementationEnsure compliance throughout the entire project lifecycle by supporting teams and anticipating issuesReview and validate testing plans, methods, and execution to ensure quality resultsLead or support the development of corrective and preventive action plans, and track software/hardware deviations across the organizationServe as a quality and regulatory advisor to IT, Quality, and Operations teams, offering best practices and compliance solutionsParticipate in selecting and evaluating computerized medical devices and applicationsAnalyze processes, risks, and system performance data to identify and monitor issuesInterpret software/hardware regulations for cross-functional teams and provide compliance guidanceStay current on industry technology and regulatory changes, while maintaining a strong professional networkKnowledge/ Education
Bachelor's degree or equivalent combination of education and experience required. Excellent knowledge of computer environments, standards development, system development life cycle, risk management and configuration management required. Knowledge of regulations as they relate to the blood industry quality and IT activities preferred. Knowledge of performance improvement, statistical tools, or cGMP systems and applications preferred.
Licenses/ Certifications
IT related certifications (i.e. ITIL, COBIT, CISA, CSQE, etc.) preferred.
Experience
Five years of related experience in an IT regulated industry required to include three years of experience in IT quality, regulatory, and/or auditing. Lean Six Sigma or other process improvement implementation and/or project management experience preferred. Use of statistical techniques and other problem-solving tools preferred.
Skills/ Abilities
Must possess the skills and abilities to successfully perform all assigned duties and responsibilities. Must be able to maintain confidentiality. Must have analytical, statistical, personal organization, and problem-solving skills. Ability to work as part of a multi-disciplinary team in a fast-paced environment.Must have proficient computer skills. Must have effective oral and written communication skills. Ability to organize, prioritize, and execute a variable workload and multiple priorities.