Principal Quality Engineer

About the role

The Principal Quality Engineer will be the liaison to cross function departments (e.g. Research and Development, Operations and etc.) with respect to investigations and/or results of investigations related to complaints. The lead is responsible for providing recommendations on product improvements as well as serve as the technical lead on large CAPA investigations where the incumbent will develop test methods to identify root/potential causes of complaints. Must be able to analyze data and assist in interpreting the data. Develop and implement investigation process improvements.

Responsibilities

• Responsible for implementing and maintaining the effectiveness of the quality system.
• Proactively utilize technical depth to understand complaints and works to improve products/process to better meet customer needs with reduced issues.
• Provides guidance with respect to applicable complaint investigation processes, and ensures compliance with regulations with respect to investigations.
• Sets global standards for specifications and drawings that properly identify and highlight critical quality attributes.
• Capture complex technical requirements in policies, design plans, investigations.
• Translates business strategy into meaningful objectives and day-to-day activities required to accomplish them.
• Anticipates future direction and adjusts current processes accordingly.
• Effectively communicates directional changes and creates support for changes.
• Be the technical lead for complaint investigations, and be liaison to other functions, such as R&D, Operations, and other Quality functions.
• Ensure investigation results are disseminated to the relevant SMEs appropriately.
• Structures studies and integrates cross-disciplinary and cross-functional issues to arrive at optimal cause of action, e.g. investigates process to meet increasing regulatory requirements while maintaining manufacturing/system construction efficiency.
• Follows through on project goals; contributes willingly and incorporates the ideas of others; shares resources, knowledge and accountability to benefit the objectives of the business, e.g. participates in team meetings; serves either as functional subject matter expert or independent technical expert in management reviews.
• Strong project management skills and able to multi-task and set priorities to meet overall business objectives.

Required Qualifications

• BS in Math, Science, or Engineering disciplines preferred, or equivalent combination of education and work experience will be considered
• Minimum 5 years of Quality experience in a FDA/ISO regulated environment.

Preferred Qualifications

• Demonstrated experience in leading teams, organizing and managing projects and developing/coaching/guiding team members (either direct and indirect reports)