Job Number: 20016651

Locations:
Dublin, OH
Miami Lakes, FL

Date Posted: 8-3-2017

Job Title: Senior Software Engineer, (Quality Management Systems CAPA)

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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

    Qualifications

  • 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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Meet Gopikrishna

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