Compliance Audit Analyst

Job Description

. 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. 

Qualifications

Auditing experience to the 21CFR820.30, 21CFR820.100, ISO13485, IS0 14971:2012, CMDR and the Medical Device Directive. 

Formal training in CAPA compliance & Investigation techniques. 

Risk Management, ISO 14971, FTA, Design FMEA, 

Comparative Statistical techniques & sampling plans. 

Additional Information

To know more about this position please contact after applying to the position on;

Sagar Rathore

sagar.rathore(at)collabera.com

630-485-2166