Internal Auditor Austin - TX - Texas

Job Title :

MDSAP Auditor Medical Device Single Audit Program Location :

Austin, TX Type :

Contract SKILL Internal Auditing

AI SUG KEY SKILLS MDSAP ISO 13485

Regulatory Compliance Quality Management Auditing

AI SUG INTERVIEW QUESTIONS

What experience do you have with MDSAP audits? Can you explain the importance of

ISO 13485

in medical device auditing? How do you stay updated with global regulatory changes? Describe a challenging audit you conducted and how you handled it? What methods do you use to communicate audit findings to clients?

ADDN NOTES JOB DESCRIPTION

We are seeking an experienced MDSAP Auditor to conduct regulatory audits under the Medical Device Single Audit Program (MDSAP) across multiple jurisdictions. The ideal candidate will be a certified auditor with extensive experience in medical device quality systems, regulatory compliance, and auditing against global regulatory requirements including FDA, Health Canada, TGA, PMDA, and ANVISA. Key Responsibilities Plan, conduct, and lead MDSAP audits in accordance with: o MDSAP Audit Model o

ISO 13485

2016 o Applicable regulatory requirements of: FDA (21 CFR 820) Health Canada TGA (Australia)

PMDAMHLW

(Japan) ANVISA (Brazil) Evaluate medical device manufacturers Quality Management Systems (QMS), including: o Risk Management o Design and Development o Production and Process Controls o CAPA o Complaint Handling and PMS Assess compliance across audit tasks such as: o Management Responsibility o Measurement, Analysis, and Improvement o Device Marketing Authorization and Facility Registration Prepare comprehensive audit reports, findings, and nonconformance classifications Communicate audit results clearly to clients and regulatory stakeholders Support follow-up activities, including CAPA review and closure Maintain auditor competence and adhere to accreditation body requirements Stay current with global regulatory updates, guidance, and MDSAP changes Thanks and Regards, Saint Singh