Job Description
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, QS...