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 or potential causes of complaints, analyze and interpret data, and develop and implement 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

• Implement and maintain the effectiveness of the quality system.
• Proactively utilize technical depth to understand complaints and work to improve products/processes to better meet customer needs with reduced issues.
• Provide guidance with respect to applicable complaint investigation processes, and ensure compliance with regulations related to investigations.
• Set global standards for specifications and drawings that properly identify and highlight critical quality attributes.
• Capture complex technical requirements in policies, design plans, and investigations.
• Translate business strategy into meaningful objectives and day-to-day activities required to accomplish them.
• Anticipate future direction and adjust current processes accordingly.
• Effectively communicate directional changes and create support for changes.
• Serve as the technical lead for complaint investigations and act as a liaison to other functions, such as R&D, Operations, and other Quality functions.
• Ensure investigation results are disseminated to the relevant SMEs appropriately.
• Structure studies and integrate cross-disciplinary and cross-functional issues to arrive at an optimal course of action, such as investigating processes to meet increasing regulatory requirements while maintaining manufacturing/system construction efficiency.
• Follow through on project goals; contribute willingly and incorporate the ideas of others; share resources, knowledge, and accountability to benefit the objectives of the business.
• Participate in team meetings; serve either as a functional subject matter expert or independent technical expert in management reviews.
• Utilize 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.
• Health and wellness benefits

What This Job Offers

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