Mark McClain
- Role
- Quality Assurance & Regulatory Affairs Compliance Manager at Edgeendo Usa
- Location
- Albuquerque, NM, US
- LinkedIn followers
- 500 followers
About Mark McClain
I am a skilled auditor capable in auditing Pharmaceutical and Medical Device firms to…
Experience
Quality Assurance & Regulatory Affairs Compliance Manager
Mar 2023 — Present
Duties include development of Quality Management System for a dental medical device distributor to compliance with 21 CFR Parts 820, 803, 806, and ISO 13485:2016 standard for medical devices certification management; Management Representative for Management Review meetings, hosting internal audits by sister device manufacturer, CAPA management, software validation and review of internal audit findings.
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