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 investigations. The incumbent will be tasked with developing test methods to pinpoint root or potential causes of complaints, analyzing and interpreting data, and enhancing investigation processes. The position involves implementing and maintaining the effectiveness of the quality system, proactively using technical expertise to understand complaints, and improving products and processes to better meet customer needs with fewer issues. The role provides guidance on complaint investigation processes, ensures regulatory compliance, and establishes global standards for specifications and drawings that highlight critical quality attributes. The Principal Quality Engineer will capture complex technical requirements in policies and design plans, translate business strategy into actionable objectives, anticipate future trends, and adjust processes accordingly. Effective communication of directional changes and fostering support for these changes are key. This role acts as the technical lead for complaint investigations and liaises with R&D, Operations, and other Quality functions, ensuring investigation results are shared with relevant Subject Matter Experts (SMEs). The position requires structuring studies and integrating cross-disciplinary and cross-functional issues to determine optimal courses of action, such as investigating processes to meet evolving regulatory requirements while maintaining manufacturing efficiency. The role involves following through on project goals, contributing to team efforts, incorporating others' ideas, and sharing resources and knowledge for business objectives. Strong project management skills are essential, with the ability to multitask and prioritize to meet business goals.

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 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.

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