The Opportunity
This position works out of our Alameda, CA location in the Diabetes Care division where we are focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology.
As Principal Quality Engineer, Tracking and Trending you will be the liaison for cross function departments (e.g. Research and Development, Operations and etc.) with respect to investigations and/or results of investigations related to Complaints Tracking and Trending. You will be responsible for developing test methods to identify root/potential causes of complaint trends.
What You’ll Work On
• 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 trend investigation processes, and ensures compliance with regulations with respect to 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.
• 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
Bachelors degree (Math, Science, or Engineering disciplines preferred) or equivalent in a technical discipline or an equivalent combination of education and work experience
Minimum 5 years of overall quality experience in an FDA/ISO regulated environment.
Demonstrated experience in leading teams, organizing and managing projects and developing/coaching/guiding team members (either direct and indirect reports).
Working knowledge of SQL, Python, PowerBI
Preferred Qualifications
Must be able to analyze data and assist in interpreting the data.
Develop and implement investigation process improvements.
Principal Quality Engineer, Tracking and Trending • Alameda, California, United States
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