Job Description
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
- 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 CFR Pa...
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