Senior Business Process Improvement Program Manager- CAPA

Medtronic
Mounds View, MN Full Time
POSTED ON 9/28/2022 CLOSED ON 10/28/2022

Job Posting for Senior Business Process Improvement Program Manager- CAPA at Medtronic

Careers That Change Lives 

This role will be 40% hybrid. Applicants must be near one of our quality “hubs” Minneapolis, Boulder/Louisville, Carlsbad, Northridge, Miami Lakes.

A career at Medtronic is like no other. We’re purposeful. We’re committed. And we’re driven by our Mission to alleviate pain, restore health and extend life for millions of people worldwide.  

In this exciting role as a Senior Business Process Improvement Program Manager, you will have responsibility over projects and processes that drive Continuous Improvement (CI), Program Management and Execution as part of Medtronic’s Customer Quality Excellence Organization. 

 

At our Customer Quality Excellence group, we focus on providing standards and centralized services for the global, enterprise-wide Customer Quality (CQ) organization for Process, Continuous Improvement and Program Management, Technology as well as partnership with our Commercial, Offshore and Regional Partners across Medtronic. 

 

A Day in the Life 

  • Responsibilities may include the following and other duties may be assigned. 
  • Provides Program Management and Continuous Improvement support and execution to the entire CQ Organization. 
  • Acts as Project Lead for ensuring CQ related CAPAs are executed effectively and timely 
  • Seeks to maximize compliance and efficiency for CAPA’s. This includes leading activities related to assessing and addressing existing and potential quality issues by performing a cause investigation and taking corrections, corrective and/or preventive actions commensurate to the risk of the issue(s). Ensures that CAPA solutions are robust and can be implemented fully within our CQ structure.  
  • Collaborates with those in CQ and in other functions to maintain quality systems policies, procedures, and practices.  
  • Ensures alignment with quality and ethical standards of the organization.  
  • Provides quality/CAPA-related oversight and investigates various input sources to verify deficiencies are corrected.  
  • Analyzes metrics, generate reports, and implement improvements to KPIs and enterprise-initiatives.  
  • Partners with the CQ Leadership team to execute the CI strategy, and the Lean transformation roadmap. 
  • Executes our Project Management strategy and manage our PM portfolio, Budget, Cost and Benefit Analyses, Tools, and Overall governance. 
  • Creates Process Flow Maps/Diagrams and evaluates existing processes. 
  • Collects data to identify root cause of problems. 
  • Measures performance against process requirements. 
  • Aligns countermeasures to address performance shortfalls. 
  • Surveys and analyzes best practices for techniques and processes. 
  • Communicates progress to a variety of stakeholders, including executive leadership 
  • Travel requirement: less than 25% 
Must Have: Minimum Requirements
 
  • Bachelors degree required
  • Minimum of 7 years of relevant experience in quality, program management, operations and/or engineering, or advanced degree with a minimum of 5 years relevant experience in quality, program management, operations and/or engineering

Nice to Have
  • 8 years’ quality experience in the medical device industry.  
  • Experience with the CAPA process (owning a CAPA, CAPA Board Member, etc).  
  • Experience with FDA 483 Inspectional Observations.  
  • Experience with supporting and/or leading complex projects.  
  • Experience supporting and participating in audits (MDSAP, EUMDR, FDA, other geography). 
  • Experience with the TrackWise application. 
  • Experience with multiple root cause investigation techniques.  
  • PMP or equivalent Certification or experience. 
  • Experience with Risk Management tools and techniques. 
  • Lean Sigma, Six Sigma, TPS or equivalent Certification or experience. 
  • Smartsheet Certification or Experience. 
  • Strong written and verbal communication skills, Ability to create and present at senior levels of the organization. 
  • Ability to handle multiple tasks concurrently. 
  • Demonstrated success in coaching, developing, and influencing others. 
     

About Medtronic


Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life.  We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let’s work together to address universal healthcare needs and improve patients’ lives. Help us shape the future.

Physical Job Requirements

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)
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