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About the Role
Key Responsibilities:
Develop and maintain effective quality systems, process controls, and methodologies to ensure compliance with regulatory, customer, and internal requirements
Support manufacturing quality activities, including product qualification, process validation, and ongoing improvement initiatives
Identify, analyze, and resolve product and process quality issues using structured problem-solving and data analysis
Lead or support investigations on nonconforming products, customer complaints, and manufacturing defects; implement corrective and preventive actions (CAPA)
Review and develop validation and test protocols; execute qualification and validation activities with proper documentation
Participate in new product introductions, technology transfers, and evaluation of new equipment and processes
Ensure compliance with Quality Management Systems (QMS) and applicable regulations (e.g., ISO13485, QSR)
Collaborate cross-functionally with engineer...
Develop and maintain effective quality systems, process controls, and methodologies to ensure compliance with regulatory, customer, and internal requirements
Support manufacturing quality activities, including product qualification, process validation, and ongoing improvement initiatives
Identify, analyze, and resolve product and process quality issues using structured problem-solving and data analysis
Lead or support investigations on nonconforming products, customer complaints, and manufacturing defects; implement corrective and preventive actions (CAPA)
Review and develop validation and test protocols; execute qualification and validation activities with proper documentation
Participate in new product introductions, technology transfers, and evaluation of new equipment and processes
Ensure compliance with Quality Management Systems (QMS) and applicable regulations (e.g., ISO13485, QSR)
Collaborate cross-functionally with engineer...
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