Information Technology is responsible for the effective development, delivery and operation of computing and information services. Anticipates, plans and delivers IT solutions and strategy which enable business value.
Essential Duties & Responsibilities: Leads the implementation and support for quality systems that enable our global medical device products business. A key area of focus is on our enterprise Quality Management System (QMS) that supports the quality disciplines of Complaints, Non-Conformance, CAPA, Audit, Recalls, Change Management and Document Management.
Partners with business segment clients, 3rd party service and SaaS providers, and international stakeholders
Demonstrates knowledge and operational understanding of enterprise quality management processes and systems within a medical device manufacturing environment that comply with Regulatory requirements
Demonstrates understanding of software development, implementation and support techniques related to managing a cloud-based quality platform
Plans and executes strategies and solutions that conforms to our enterprise and business segment vision to minimize risk of system/client outages or other negative production impacts
Demonstrates conceptual and working knowledge of architecture standards, database technologies, operating systems, governance and platform management practices
Demonstrates problem solving ability that allows for effective and timely resolution of system failures including but not limited to production outages.
Analyzes production system operations using monitoring and capacity planning tools, data trends, and root cause analysis to identify and drive change that ensures continuous improvement in system stability and performance.
Demonstrates knowledge of software development life cycle, modeling of business processes, application design patterns, and the need for functional business artifacts
Provides guidance and instruction for operational process improvement that reduces service cost, and improves speed to market of solutions
Competencies: Expectations at this level - Center of Expertise for functional success
Uses deep medical device manufacturing subject matter/functional expertise, and process skills to help internal/external customers and stakeholders identify and meet their high priority needs while considering known system and environmental constraints
Encourages informed risk-taking and acts as a catalyst for innovation; generates practical, sustainable and creative options to solve operational problems, and provide business value to the global client base
Proactively develops and maintains technical knowledge in specialized area(s), remaining up-to-date on current trends in device quality management and best practices in the Life/Health Science discipline
Performs assessments and listens to internal/external customers to understand and anticipate their needs and determine their priorities in the context of the overall enterprise quality vision
Accountabilities in this role
Manages vendor partners with accountability for department operations for build and run activities in a SaaS Cloud configuration
Participates in the development of policies and procedures to achieve department goals, and meet financial targets
Interacts with peer, clients, customers and vendors at various management levels with professional distinction
Gains consensus from various parties involved to advance key operational initiatives
Maintains professional engagement and continuous dialog with business clients to ensure smooth transition of work, and meet/exceed client expectations
Bachelor's degree, preferably in related field, and prior work experience in the Medical Device Manufacturing industry/practice
8+ years’ experience in related Quality management field managing or leading Build & Run Application Support teams
Working knowledge of three or more technologies preferred
Proven leadership ability preferred
Must have a strong understanding and experience with quality, regulatory, and FDA processes within the medical device manufacturing industry
Experience in gathering requirements, assisting creating the functional specs, and performing in the role of application solution manager
Experience within the Quality Management System (QMS) that supports the quality disciplines of Complaints, Non-Conformance, CAPA, Audit, Recalls, Change Management and Document Management that comply with Regulatory requirements is a must
Worked with SaaS vendors to manage cloud solutions
Ability to define work processes and lead team members in successful implementation and ongoing execution
Ability to develop individuals along a professional career path
Excellent oral and written communication skills
Excellent organizational, governance, and functional technical acumen
Strong analytical, troubleshooting and problem resolution skills
What Software Engineering contributes to Cardinal Health
Software Engineering is responsible for designing, developing, implementing and supporting applications, systems and IT products required to achieve the company's business objectives.
Demonstrates knowledge of software development techniques and fluency in software languages and application programming interfaces.
Demonstrates general understanding of hardware/software platforms including but not limited to operating systems, databases, application servers, web servers and integration technologies.
Plans and executes system implementations that ensure success and minimize risk of system outages or other negative production impacts.
Demonstrates conceptual knowledge of architecture standards and database and operating systems.
Demonstrates problem solving ability that allows for effective and timely resolution of system issues including but not limited to production outages.
Analyzes production system operations using tools such as monitoring, capacity analysis and outage root cause analysis to identify and drive change that ensures continuous improvement in system stability and performance.
Demonstrates knowledge of software development, life cycle, modeling of business processes, application design patterns, business/functional documents. Estimates to high level business requirements and provide options analysis.
What is expected of you and others at this level
Applies advanced knowledge and understanding of concepts, principles, and technical capabilities to manage a wide variety of projects
Participates in the development of policies and procedures to achieve specific goals
Recommends new practices, processes, metrics, or models
Works on or may lead complex projects of large scope
Projects may have significant and long-term impact
Provides solutions which may set precedent
Independently determines method for completion of new projects
Receives guidance on overall project objectives
Acts as a mentor to less experienced colleagues
Cardinal Health is an Equal Opportunity/Affirmative Action employer.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex,
sexual orientation, gender identity, national origin, disability, or protected veteran status.
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I started my career as an IT programming analyst and have progressed into management. Cardinal Health provides various training programs to help individuals be successful in their job and grow professionally.
This is a great place to work because the people here strive to make a great difference in healthcare every day.
Gopikrishna, Manager, Software Engineering