Principal Quality Engineer

Abbott • Alameda, CA

5d • Onsite

About The Position

The Principal Quality Engineer will serve as the liaison to cross-functional departments, including Research and Development and Operations, regarding investigations and/or results of investigations related to complaints. This role is responsible for providing recommendations on product improvements and acting as the technical lead on large CAPA investigations. The incumbent will develop test methods to identify root/potential causes of complaints, analyze and interpret data, and develop and implement investigation process improvements.

Requirements

• 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.

Nice To Haves

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

Responsibilities

• Implementing and maintaining the effectiveness of the quality system.
• Proactively utilizing technical depth to understand complaints and working to improve products/processes to better meet customer needs with reduced issues.
• Providing guidance with respect to applicable complaint investigation processes, and ensuring compliance with regulations with respect to investigations.
• Setting global standards for specifications and drawings that properly identify and highlight critical quality attributes.
• Capturing complex technical requirements in policies, design plans, and investigations.
• Translating business strategy into meaningful objectives and day-to-day activities required to accomplish them.
• Anticipating future direction and adjusting current processes accordingly.
• Effectively communicating directional changes and creating support for changes.
• Serving as the technical lead for complaint investigations and as a liaison to other functions, such as R&D, Operations, and other Quality functions.
• Ensuring investigation results are disseminated to the relevant SMEs appropriately.
• Structuring studies and integrating cross-disciplinary and cross-functional issues to arrive at optimal cause of action, e.g., investigating processes to meet increasing regulatory requirements while maintaining manufacturing/system construction efficiency.
• Following through on project goals; contributing willingly and incorporating the ideas of others; sharing resources, knowledge, and accountability to benefit the objectives of the business, e.g., participating in team meetings; serving either as functional subject matter expert or independent technical expert in management reviews.
• Demonstrating strong project management skills and the ability to multi-task and set priorities to meet overall business objectives.

Benefits

• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a high employer contribution.
• Tuition reimbursement, the Freedom 2 Save student debt program, and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.

What This Job Offers

• Job Type: Full-time
• Career Level: Principal