Quality Engineer
Quality Engineer
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Salary Not Disclosed
1 Vacancy
Job Description
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.
Employment Type
Full-time
