Principal Quality Engineer, Tracking and Trending

Regulatory Jobs; Alameda (CA); Presencial; USD 114.000 - 228.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health benefits

Retirement plan

Tuition reimbursement

FreeU education benefit

Descripción de la vacante

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

Formación

• 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

Responsabilidades

• 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.

Conocimientos

SQL

Python

PowerBI

Educación

Bachelors in STEM

Descripción del empleo

JOB DESCRIPTION:

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and your family, be your true self, and live a full life. You’ll also have access to:

• 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, 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.

The Opportunity

This position works out of our Alameda, CA location in the Diabetes Care division where we are focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology.

As Principal Quality Engineer, Tracking and Trending you will be the liaison for cross function departments (e.g. Research and Development, Operations and etc.) with respect to investigations and/or results of investigations related to Complaints Tracking and Trending. You will be responsible for developing test methods to identify root/potential causes of complaint trends.

What You’ll Work On

• 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.

Required Qualifications

Bachelors degree (Math, Science, or Engineering disciplines preferred) or equivalent in a technical discipline or an equivalent combination of education and work experience

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

Preferred Qualifications

Must be able to analyze data and assist in interpreting the data.

Develop and implement investigation process improvements.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: https://abbottbenefits.com/

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at abbott.com, on LinkedIn at https://www.linkedin.com/company/abbott-/, and on Facebook at https://www.facebook.com/AbbottCareers.

The base pay for this position is

$114,000.00 – $228,000.00

In specific locations, the pay range may vary from the range posted.

JOB FAMILY:

Operations Quality

DIVISION:

ADC Diabetes Care

LOCATION:

United States > Alameda : 1360-1380 South Loop Road

ADDITIONAL LOCATIONS:

WORK SHIFT:

Standard

TRAVEL:

Yes, 15 % of the Time

MEDICAL SURVEILLANCE:

No

SIGNIFICANT WORK ACTIVITIES:

Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Keyboard use (greater or equal to 50% of the workday)Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdfEEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf