Senior Quality Engineer, Tracking & Trending

Regulatory Jobs; Alameda (CA); On-site; USD 114,000 - 228,000; Full time

Benefits offered by this job

Health benefits

Retirement plan

Tuition reimbursement

FreeU education benefit

Job summary

Abbott in Alameda, CA, seeks a Principal Quality Engineer, Tracking and Trending, to lead complaints investigations and root-cause analyses in the Diabetes Care division. You will collaborate with R&D, Operations, and other Quality teams to drive investigations and improve product quality.

Responsibilities include designing test methods, guiding trend investigations, and ensuring regulatory compliance while translating strategy into actionable objectives and managing multiple projects

Qualifications

• Bachelor's degree in Math, Science, or Engineering or equivalent in technical discipline.
• Minimum 5 years of overall quality experience in an FDA/ISO regulated environment.
• Demonstrated experience in leading teams, organizing and managing projects and developing/coaching/guiding team members (either direct and indirect reports).
• Working knowledge of SQL, Python, PowerBI

Responsibilities

• 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 trend investigation processes, and ensures compliance with regulations with respect to 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.
• 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.

Skills

SQL

Python

PowerBI

Education

Bachelors in STEM

Job description

Abbott in Alameda, CA, seeks a Principal Quality Engineer, Tracking and Trending, to lead complaints investigations and root-cause analyses in the Diabetes Care division. You will collaborate with R&D, Operations, and other Quality teams to drive investigations and improve product quality.

Responsibilities include designing test methods, guiding trend investigations, and ensuring regulatory compliance while translating strategy into actionable objectives and managing multiple projects