Quality Systems Engineer

Responsibilities

• Provide quality support to production lines and catheter assembly processes
• Ensure compliance with GMP, GDP, and ISO 13485 requirements
• Investigate NCRs, process deviations, and manufacturing failures
• Lead root cause analysis activities using 8D, 5 Why’s, Fishbone, and CAPA methodologies
• Monitor quality KPIs, scrap trends, and rework performance
• Support process validations, engineering changes, and continuous improvement initiatives
• Participate in internal, corporate, and regulatory audits
• Collaborate with Manufacturing, Process Engineering, Validation, and Quality teams

Qualifications

• Bachelor’s degree in Engineering or related field
• 2–3 years of experience as a Quality Engineer within the medical device industry
• Experience in catheter manufacturing or medical device assembly operations
• Knowledge of ISO 13485, FDA 21...