Sr. Engineer, QA

Job Description Summary

Role Purpose

Applies knowledge of quality engineering principles and methods to ensure compliance with regulatory requirements and systems/procedures to optimize product development, internal and external device manufacturing, and device distribution. Directs risk assessment activities as part of process improvements by looking into current issues with product and related manufacturing processes. Further, the quality engineer is developing the quality management system continuously.

Job Description

Job Functions

Develops and maintains methods and sampling procedures for inspections, testing and evaluation. Supports Quality Operations to ensure that products and processes comply with the relevant requirements of the Quality Management System.

Identify and ensure the optimization of complex Manufacturing and/or R&D processes using engineering methods (e.g., SIX Sigma and LEAN methods) for design for manufacturing and for continuous process improvement. Identify opportunities for re-design/design of basic equipment, tools, fixtures, etc. to improve manufacturing processes, and reduce risk.

Responsible for assuring validation / qualification of equipment, (including software and process following appropriate procedures and meeting regulatory compliance requirements.

Responsible for leading multifunctional teams to develop risk assessment activities, as part of Advanced Quality Planning system; creating and maintaining files including Process Map, FMEA and Plans for controlling product quality. Supports process improvement plans and strategies that are designed to mitigate the risks identified through Risk Management process. Develop, update, and maintain technical content of risk management files.

Develop training and documentation materials for production (e.g., work

instructions) to enable the seamless knowledge transfer of project and

manufacturing processes.

Support product/process transfer projects to assure compliance with procedures, as well as facilitation of activities required in the transfer.

Investigate complex manufacturing product quality and compliance issues (e.g, CAPA, non-conformances, audit observations) for all production processes prior to final product release based on engineering principles; analyze results, make recommendations and develop reports.