CAPA Compliance Quality Specialist

Summary of Position: 

Develops and manages the process that establishes and maintains quality assurance and regulatory programs, policies, processes, procedures and controls to ensure that the performance and quality of products conform to established standards and agency guidelines 

Essential Functions: 

1. Manage CAPA workstream, CAPA investigations, CAPA & compliance audit trending of quality data streams. 

2. Develop & establish continuously improving plans for site CAPA system, quality assurance programs & quality policies. 

3. Plan, schedule & execute internal quality audits program for ventilation design sites. 

4. Lead a team of auditor(s) to perform audits / assessments by collecting and analyzing objective evidence regarding issues and risks. Report findings (verbally and written) to management. 

5. Evaluate corrective and preventive action responses to the assessment findings for adequacy, including root cause and timeliness. Elevate issues to management, as appropriate. 

6. Provide expertise and guidance in interpreting governmental regulations, agency guidelines and internal policies to assure compliance. 

7. Develop and maintain compliance policies supporting the Respiratory and Monitoring quality system. 

8. Lead process improvement projects and conduct training with Quality to improve the GBUs overall quality system compliance. 

9. Assist with site regulatory compliance specific needs such as external audit preparation, assessment of quality plans, responses to internal and external audit observations. 

10. Maintain working knowledge of existing and proposed domestic and international medical device regulations and guidance documents and their impact on Medtronic's operations. 

11. Prepare management reports depicting trends and useful data for management review purposes. 

12. Support management during external inspections and participate in the management of external inspections as required. 

To know more about this opportunity, please contact:

Sagar Rathore
630-485-2166

sagar.rathore(at)collabera.com