Principal Quality Engineer

Abbott; United States; On-site; USD 110,000 - 170,000; Full time

Benefits offered by this job

Free medical coverage

High-contribution retirement plan

Tuition reimbursement

FreeU education benefit

Job summary

Abbott is seeking a Principal Quality Engineer to serve as the technical lead on large CAPA investigations, liaise with R&D, Operations and other Quality functions, and develop robust test methods to identify root and potential causes of complaints.

The role requires implementing and maintaining the quality system, translating business strategy into concrete objectives, guiding cross‑functional teams, and ensuring investigations are compliant with FDA/ISO regulations while driving continuous

Qualifications

• BS in Math, Science, or Engineering preferred, or equivalent combination of education and work experience will be considered
• Minimum 5 years of Quality experience in a FDA/ISO regulated environment.

Responsibilities

• Implement and maintain the quality system.
• Proactively address complaints and drive product/process improvements to meet customer needs.
• Provide guidance on complaint investigation processes and ensure regulatory compliance.
• Set global standards for specifications and drawings highlighting critical quality attributes.
• Capture complex technical requirements in policies, design plans, and investigations.
• Translate business strategy into objectives and daily actions.
• Lead cross‑functional investigations and disseminate results to SMEs.

Skills

Quality assurance

CAPA investigations

Regulatory compliance

Project management

Education

BS in Math, Science, or Engineering

Job description

Principal Quality Engineer

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 122,000 colleagues serve people in more than 160 countries.

Working at Abbott

• 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.

The Opportunity

The Principal Quality Engineer will be the liaison to cross function departments (e.g. Research and Development, Operations and etc.) with respect to investigations and/or results of investigations related to complaints. The lead is responsible for providing recommendations on product improvements as well as serve as the technical lead on large CAPA investigations where the incumbent will develop test methods to identify root/potential causes of complaints. Must be able to analyze data and assist in interpreting the data. Develop and implement investigation process improvements.

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 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.

Required Qualifications

• 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.

Preferred Qualifications

• Demonstrated experience in leading teams, organizing and managing projects and developing/coaching/guiding team members (either direct and indirect reports)

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

Abbott is an Equal Opportunity Employer, committed to employee diversity.

Divisional Information

Medical Devices

General Medical Devices: Our medical devices help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks.

CRM As a global leader in Cardiac R