Quality Engineer

Job Description

• Apply quality engineering principles to analyze quality records, prepare reports, and recommend process or product improvements.
• Conduct inspection, verification, and validation of components or materials used in development and production processes.
• Identify and address recurring quality issues related to product performance.
• Document quality issues, non-conformances, and performance metrics for management review and continuous improvement initiatives.
• Support root cause analysis and corrective / preventive actions (CAPA).
• Assist in maintaining compliance with ISO 13485, FDA 21 CFR Part 820, and other applicable regulatory requirements.
• Participate in internal audits and support external audits as needed.
• Collaborate with engineering, manufacturing, and supply chain teams to ensure product quality and reliability.

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