Job Description

Responsibilities:

• Review and execute IQ, OQ, PQ protocols for equipment and processes.
• Conduct process audits and update QMS documentation .
• Perform process optimization using DoE for CNC Machining and DCM.
• Conduct validation, verification, and qualification activities with detailed reporting.
• Use statistical tools (Minitab/JMP) to analyze process performance and variability.
• Lead change management and implement process improvements .
• Support manufacturing, troubleshooting, and cross-functional teams on production floor issues.
• Ensure compliance with FDA, ISO 13485, and GMP standards .

Requirements:

• Bachelor’s/Master’s in Mechanical, Biomedical, or related Engineering .
• 8+ years in medical device manufacturing (CNC & DCM experience required).
• Strong knowledge of IQ/OQ/PQ, TMV, QMS, and ERP systems .
• Skilled in statistical analysis and problem-solving .
• Excellent communication and documentation skills.

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