Staff Quality Engineer

Accountabilities:

• Develop and implement reliability analysis, design, validation and assessment methods to support successful new product introductions and or sustaining product changes

• Provide quality leadership to new product development teams in the areas of design control, design verification and validation, design transfer, process validation, risk management, and specification development

. • Drive product risk management activities and ensure quality and completeness of project design history files, validation packages, and change orders

• Provide ongoing quality engineering support throughout the product life cycle. Provide support to development, engineering and manufacturing functions for validation planning and transfer activities. Assist teams in determining validation needs strategies and requirements. Ensure product development and validation programs meet requirements of FDA and ISO when applicable

• Work with Engineering and R&D to develop reliability testing plus modeling methods specific to products and systems for HALT, Shock and Vibration, Weibull, MTBF and others as required

• Set Reliability goals for products and their subsystems in the field and measure against progress. Maintain a knowledge base of lessons learned to enable continuous improvement

• Manage and assess reliability risks that could adversely affect operations by providing analysis, diagnostics, and reporting. This will involve data analysis techniques to help companies meet accepted reliability standards.

• Writes detailed Risk Assessments, updates Process Hazard Analysis, and present analysis to the Risk Management Board

• Trend, analyze, and report on quality data in order to improve product and process; develop recommendations based on data analysis

• Provide management with status updates on assigned responsibilities and goals and escalate issues in a timely fashion