Quality Engineer

• Support transfer of New Product Introduction to high volume manufacturing and develop quality control plans.

• Implement and maintain, as a team member, Standard Operating Procedures, Process flow charts, Process Control Plans, Process FMEA, and Validations.

• Manage Non-conformance, CAPA and Complaint (internal and external) processes; ensure root cause analysis and effectively implement robust action plans. Follow-up and verification of CAPAs to ensure no recurrence. Facilitate the closures of these in a timely manner.

• Provide Manufacturing Quality Trend Charts/Analysis and suggest/implement continuous improvement practices, including appropriate kaizen events on relevant processes based on trends. Support shin Kaizen events and use Lean manufacturing principles, as and when required. Roll out CDT&R, VOP, DRS, PSP, FMEA- utilize DBS to drive continuous improvements.

• Support Supplier Quality Engineer for driving improvements for Supplier related issues (SCARs), work closely with Purchasing/Sourcing departments to select/maintain/drop suppliers list based on their performance

It would be a plus if you also possess previous experience in:

• Knowledge of the following software/systems: Veeva, SAP, Magic (Enovia).

• Product line transfers and new product introduction

• Customer facing technical writing and conflict resolution