Sr. Engineer Quality

Key Responsibilities :

1.Develop and maintain quality standards, identify issues, and recommend solutions to improve in-process, supplier, and final quality.

2.Analyze rejection & defects using analytical and statistical tools, implement solutions, and prevent repetitive issues.

3.Execute projects for quality and process connectivity through digital initiatives.

4.Implement and oversee a Quality Management System in compliance with corporate policies, regulatory requirements, and industry guidance.

5.Manage document control, change management, and supplier quality, including audits.

6.Conduct robust root cause analysis and CAPA for rejection.

7.Implement an effective internal audit program and ensure adequate training.

8.Execute applicable validation master plans for equipment, processes, products, sterilization, and test methods.

9.Ensure cleanroom practices and drive the team towards a zero-defect culture.

10.Monitor process changes, conduct statistical studies, interface with customers, and perform 8D analysis.

This role requires a proactive approach to quality assurance, strong analytical skills, and the ability to lead digital transformation projects. Familiarity with ISO9001 : 2015 and quality tools like 7 QC and 8D analysis is essential.