Abbott Principle Engineer Quality in Alameda, California
At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
The technical lead 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.
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.
Bachelors Degree in Math, Science, or Engineering disciplines preferred) or equivalent in a technical discipline or equivalent experience
Minimum 5 years of overall quality experience in a FDA/ISO regulated environment.
Demonstrated experience in leading teams, organizing and managing projects and developing/coaching/guiding team members (either direct and indirect reports).
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email firstname.lastname@example.org