CVS Health

Remote/Telecommute

Technical Business Process Owner

Posted over 1 month ago

Job Description

Job Description
The Technical Business Process Owner for CVS Kidney Care will play a critical role in supporting the HemoCare system, from a business process perspective. This position will be recognized as a subject matter expert (SME) in elements of medical device regulations related to Quality Systems, Design Controls and more specifically Complaint Handling. The ideal candidate will not only have good working knowledge of the Design Control regulations, but also efficient Root Cause Analysis methods. Additionally, they will have experience in configuration of PLM &/or Change Management Systems. This resource will work in close collaboration with our design partners, digital teams, IT resources and business stakeholders to ensure our integrated systems are enabling effective and complaint management of our home hemodialysis system.

This individual will be responsible for ensuring our customer needs are met on a timely basis. This positions primary responsibility is to lead the effective implementation of IT solutions and business processes to ensure effective management of the CVS HemoCare system across our stakeholder landscape. Key responsibilities are below.

- Development and Integration of Design Control business processes and IT tools as it relates to Change Management, Configuration Management and Complaint Handling
- Works with the Engineering Team in the application of metrics on business processes from Change Control and Complaint Handling to Service and Manufacturing
- Supports the development of internal Quality procedures as it relates to Design Controls, especially Change Management, Configuration Management and Complaint Handling
- Oversees and supports Complaint Trending and the corresponding CAPA investigations on all products associated with HemoCare system and its therapy delivery
- Take the lead on tracking improvement opportunities related to the production, integration and servicing across the product offering portfolio
- Work closely and collaboratively with our design partners to ensure optimal design of business processes for seamless business-to-business integration

Required Qualifications
- 7+ years of Medical Device experience in Product Development and Lifecycle Management

Preferred Qualifications
- 3+ years of direct experience in dialysis or blood purification consumables &/or disposables
- Lean Six Sigma Certification preferred
- Application of Lean principles in Technical Service environment
- Experience in Complaint Handling and CAPAs
- Experience in the implementation of Design Control and Change Control processes
- Experience in configuration and implementation of PLM and Complaint Handling applications
- Ability to work in a fast-paced, dynamic environment
- Knowledge of DMAIC and Root Cause Analysis
- Application Lifecycle Management - specifically PLM and Complaint Handling applications
- Managing IT tools configuration and implementation
- Ability to apply meaningful metrics and quantify key improvement markers

Education
Bachelors Degree required.
Advanced Degree in Engineering or Science preferred.

Business Overview
At CVS Health, we are joined in a common purpose: helping people on their path to better health. We are working to transform health care through innovations that make quality care more accessible, easier to use, less expensive and patient-focused. Working together and organizing around the individual, we are pioneering a new approach to total health that puts people at the heart.


We strive to promote and sustain a culture of diversity, inclusion and belonging every day. CVS Health is an equal opportunity and affirmative action employer. We do not discriminate in recruiting, hiring or promotion based on race, ethnicity, sex/gender, sexual orientation, gender identity or expression, age, disability or protected veteran status or on any other basis or characteristic prohibited by applicable federal, state, or local law. We proudly support and encourage people with military experience (active, veterans, reservists and National Guard) as well as military spouses to apply for CVS Health job opportunities.

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