Mark Perkins
Medical Device QA/RA Consulting
- Role
- Director Quality Assurance and Regulatory Affairs at Noah Medical
- Location
- Canyon Lake, TX, US
- LinkedIn followers
- 500 followers
About Mark Perkins
Specialties: Internal Audits, CAPA, Complaint Handling, Corrections and Removals, MDR / Adverse Event Reporting, Process Validations, FMEA, FDA Inspections, ISO 13485 / CE Marking Audits / EU MDR / MDSAP / Training
Experience
Director Quality Assurance and Regulatory Affairs
Jan 2025 — Present · San Francisco, CA, US
Responsible for Quality Assurance and Regulatory Affairs oversight within the Quality Assurance function as well as Management Representative responsibility. Established Critical CAPA Review teams in response to FDA 483 and subsequent Warning Letter and provided monthly progress updates to FDA 483 responses. Developed and delivered CAPA training to CAPA owners to ensure appropriate CAPA methods and documentation. Developed Quality Plan and led team efforts for multiple remediation activities.
Education
Texas A&M University
Bachelor of Science, Industrial Engineering
1978 — 1983
San Diego State University
Regulatory Affairs
2005 — 2006
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