CVS Health

Remote/Telecommute

Senior Quality Manager

Posted over 1 month ago

Job Description

Job Description
The Quality Lead for CVS Kidney Care Advanced Technologies 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 specifically Complaint Handling. This position will oversee the Technical Service Organization compliance with FDA QSR, ISO 13485 and AAMI, as well as, alignment with the company objectives and Quality Standards. The ideal candidate will use a risk-based approach to lead the Advanced Technologies Quality Operations Group to ensure a robust, sustainable and cost-effective Quality System that is aligned with internal and external customer expectations.

This individual will be responsible for ensuring our customer needs are met on a timely basis. The primary responsibility for this position are listed below.

- Manage and lead regulatory inspections conducted at Advanced Technologies
- Provide leadership and management of the Advanced Technologies QA Department
- Boldly innovates in the space of Digital Health. Contributes to the definition and delivery of a future-state operating model to support the design, build, deployment and lifecycle management of patient-facing and field tech digital assets
- Oversee internal process/system audits, external investigations and vendor audits
- Assist in the development of training requirements for Advanced Technologies
- Actively participate in the Advanced Technologies CAPA program, quality data analysis/trending and continuous process improvement initiatives
- Provide QA representation in project meetings, governance activities, as needed
- Provide internal consulting to project-teams as needed
- Collaborate with external partners
- Define the adequate organizational structure to ensure a sustainable Quality System across Technical Operations
- Define and deploy quality metrics/KPI for Quality group

Required Qualifications
-10+ years of Medical Device experience in a Quality System, Product Development, Manufacturing and/or Lifecycle Management.

Preferred Qualifications
- Direct experience in Complaint Handling and CAPAs
- Direct experience in the implementation of Design Control, Change Control and Part 11 Computerize Systems
- Direct experience in configuration and implementation of 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
- Demonstrated proficiency and experience in working with Quality Systems IT applications
- Ability to apply meaningful metrics and quantify key improvement markers
- Ability to create and deliver presentations to key stakeholders that effectively communicate key findings, and summarize insights and implications to communication strategies
- 3+ years of direct experience in dialysis or blood purification consumables &/or disposables
- ASQ CQA, CQE or CQM preferred
- Application of Lean principles in Technical Service environment

Education
Bachelors degree in Engineering or related discipline.
Advanced Degree in Engineering or Science is 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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