Key Responsibilities:
Ensure compliance with USFDA, GMP, and ISO 13485 requirements.
Maintain and review quality documentation and records.
Support CAPA, deviation, change control, and non-conformance management.
Assist in internal audits, regulatory inspections, and quality system activities.
Ensure adherence to SOPs and quality standards.
Key Skills:
Knowledge of USFDA regulations and Quality Management Systems (QMS).
Documentation and record management.
CAPA, deviation handling, and root cause analysis.
Audit readiness and regulatory compliance.
Attention to detail and effective communication.
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