Principal Quality Engineer

Abbott • Alameda, CA

2d • $114,000 - $228,000 • Onsite

About The Position

The Principal Quality Engineer will serve as the primary liaison between cross-functional departments, including Research and Development and Operations, concerning complaint investigations and their outcomes. This role is responsible for recommending product improvements and acting as the technical lead for significant CAPA (Corrective and Preventive Action) investigations. The incumbent will be tasked with developing test methods to identify the root or potential causes of complaints and will be expected to analyze and interpret data. Additionally, the role involves developing and implementing improvements to the investigation process.

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 acting 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.
• Utilizing strong project management skills and the ability to multi-task and set priorities to meet overall business objectives.

Benefits

• Career development with an international company where you can grow the career you dream of.
• 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.
• A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as the best place to work for diversity, working mothers, female executives, and scientists.

What This Job Offers

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