Quality Engineer
Seeking a Quality Engineer with experience in manufacturing processes, process validation, CAPA, and medical devices. Responsible for ensuring compliance with quality standards, supporting validation activities, and driving continuous improvement initiatives within a regulated environment.
Roles & Responsibilities:
- Support manufacturing process validation (IQ/OQ/PQ) to ensure compliance with regulatory standards.
- Lead and participate in CAPA investigations, root cause analysis, and implementation of corrective/preventive actions.
- Review and maintain documentation for validation protocols, reports, and quality records.
- Collaborate with cross-functional teams (Manufacturing, R&D, Quality) to resolve quality issues.
- Ensure compliance with FDA, ISO 13485, and GMP requirements for medical devices.
- Drive continuous improvement initiatives to enhance product quality and manufacturing efficiency.
- Support internal and external audits/inspections as required.
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