Cardinal Health Quality Engineer, Software Engineering (Quality Management Systems CAPA) in Dublin, Ohio
Working together, we can make a difference in healthcare for our customers and communities. Your contributions, along with colleagues around the world, are helping make healthcare safer and more productive every day.
Essential Duties & Responsibilities:
Support the a global user base of our medical device products business with primary focus 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, to manage the upkeep and on-going support of the enterprise QMS.
- 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 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
Competencies: Expectations at this level - Center of Expertise for functional success
- Uses 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
- 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
- Facilitates the team through the analysis of, and makes recommendations towards, complex business decisions.
- Mediates across different IT teams utilizing knowledge of IT and roles and responsibilities within the organization.
- Focuses on process analysis and re-engineering, with an understanding of technical problems and solutions as they relate to the current and future business environment.
- Demonstrates excellent listening, communication, and facilitation skills.
- Lead collaborative requirement sessions with end users & IT resources to document use cases, ensure user work flows are understood and for requirements sign-off and baseline.
- The candidate must have experience with project methodologies such as Agile and Water Fall.
- Candidate must be familiar with HP ALM and have great written and verbal communication skills.
- Candidate must have the ability to report findings/status to project team and stakeholders throughout the life of a project.
- The candidate must have a track record for contributing to small to large complex projects, work in group settings and have the ability to work autonomously.
Accountabilities in this role
- Partners with the platform Operations group, & vendor partners for all DevOps activities in a SaaS Cloud configuration
- Participates in the development of policies and procedures to achieve department goals, platform operational targets, and end user satisfaction
- 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
- 4+ years experience in related field preferred
- Working knowledge of two or more technologies preferred
- Experience in the Health Care/Life sciences and/or FDA Compliance disciplines.
- Detailed knowledge of application development process, agile methodologies, and Quality Management Systems.
- 4 + years’ experience in related Quality management field managing or leading DevOps Application Support teams
- Worked with SaaS vendors to manage cloud solutions
- 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 comprehensive knowledge and a thorough understanding of concepts, principles, and technical capabilities to perform varied tasks and projects
- May contribute to the development of policies and procedures
- Works on complex projects of large scope
- Develops technical solutions to a wide range of difficult problems. Solutions are innovative and consistent with organization objectives
- Completes work independently receives general guidance on new projects
- Work reviewed for purpose of meeting objectives
- May act 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.