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Quality
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19000ISO Requisition #

Careers That Change Lives

 

In this exciting role as a Sr. CAPA Specialist you will have responsibility for compliance to Corrective and Preventative Action (CAPA) processes and Medical Device regulations and requirements by serving as a subject matter expert and providing guidance to CAPA owners and working closely with CAPA Board Members in the development of CAPA activities and the rigorous assessment of CAPA documentation.  Additionally, you will be supporting internal audits and external regulatory agency inspections.

CVG CORONARY AND STRUCTURAL HEART provides interventional devices to treat coronary arteries that are blocked by atherosclerotic plaque and devices and therapies to treat structural defects of the heart.

 
A Day in the Life
 

 • Provides continuous and rigorous assessment of CAPA activities and documentation to assure compliance with CAPA processes, FDA regulations, ISO 13485, and Medical Device Requirements through the review of CAPA records at critical phases

• Provides guidance, support and mentors CAPA Owners, CAPA Board Members and CAPA Board Chairs regarding the CAPA process, CAPA best practices, CAPA record content, and CAPA software tools.

• Support CAPA Board Chairs and CAPA Board Members with metrics and reporting on critical aspects regarding the health of the CAPA process.

• Participates in CAPA Board activity and performs CAPA Specialist role for multiple Coronary and Structural Heart sites.

• Completes tasks assigned in support of CVG CAPA Council.

• Supports the development and implementation of Quality System CAPA procedures, CAPA software, and CAPA training programs.

• Supports internal and external audits and inspections for CAPA records and processes and other roles as needed.

Works directly with operating entities to provide process analyses oversight on a continuing basis to enforce requirements and meet regulations.

• Leads audit and inspection preparation, resolution of audit and inspection findings and liaises with auditing groups and inspectors through all stages of the audits. Partners with functions in preparation of and provides support during internal and external audits.

• Prepares reports and/or necessary documentation (ex Corrective and Preventative Actions) and provides to applicable stakeholders, both internal and external.

• Performs other related duties as assigned.


Must Have: Minimum Requirements

 

To be considered for this role, please ensure the minimum requirements are evident on your resume.

 

Bachelor’s degree with 4+ years in quality or manufacturing or Advanced degree with 2+ years in quality or manufacturing

 
 
Nice to Have
  • Experience in a regulated environment
  • Experience working with nonconformances, corrective and preventive actions
  • Experience in audits and inspections
  • Experience in medical device, pharmaceutical and/or a comparable regulated environment
  • Influence management skills; ability to work constructively across all functions of the organization as well as external customers
  • Project management skills
  • CAPA documentation systems experience (e.g. Trackwise)
  • Experience reviewing technical documentation
  • Strong written and verbal communication skills
  • Ability to educate people in the CAPA program
  • Experience with quality tools and process improvement techniques
  • Knowledge of effective root cause investigation, corrective and preventive action planning and execution and verification of effectiveness techniques
  • Strong analytical and decision-making skills
  • Understanding of FDA regulations (21 CFR 820, 210/211 as applicable and Part 11), ISO 13485, and Medtronic quality requirements in general and specific to CAPA
 

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)

 
Travel both domestic and international are applicable. 
 
 
 

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