Accountable for compliance to FDA 21 CFR Part 820, ISO 13485:2016 and other applicable regulatory requirements for the site operations, including, but not limited to:
Ensure execution and compliance of all QMS processes, including training, resource management, production controls, equipment control, non-conformance, CAPAs, audits, acceptance activities, etc.
Support the investigation of technical problems and evaluate & implement solutions.
Serving as primary contact in any audit by a regulatory authority and lead all audit communications.
Engage team in day to day activities, specially related to site operations and improvement projects.
Reporting on the performance and effectiveness of the quality system and any need for improvement to the executive management for review.
Education, Experience and Background Requirements
7+ years of experience in a quality role at a medical device company.
Background/education in engineering/science or related field.
Training and Skills Requirements
Strong communication skills and experience working in small teams.
Experience with FDA 21 CFR Part 820, ISO 13485:2016.
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