Lead Engineer Quality

Thornton Tomasetti; Alameda (CA); On-site; USD 100,000 - 200,000; Full time

Job summary

Abbott Alameda is seeking a Lead Quality Engineer to own investigations of complex product complaints and CAPA‑driven actions in the Diabetes Care division. You will work to identify root causes and drive effective corrective actions across teams.

The role requires a strong technical understanding of the product and investigation methods, with cross‑functional collaboration with Operations, R&D, QA, and Customer Service to ensure timely resolutions.

Qualifications

• Bachelor’s degree with a minimum of 8 years of experience in Quality Assurance or a related field required.
• An equivalent combination of education and experience, including a minimum of 12 years of relevant experience, will also be considered.
• Demonstrated initiative and problem‑solving skills; critical‑thinking skills, preferably in a CAPA environment.
• Experience working cross‑functionally in an investigative role in a Quality management system.
• Quality Assurance and healthcare industry disciplines preferred.
• Minimum 4 years overall quality experience in an FDA/ISO regulated environment preferred.

Responsibilities

• Isolate root causes and implement effective solutions by means of sophisticated analysis and investigative techniques for product issues.
• Responsible for establishing ADC investigation and reporting methodology as pertaining to elevated complaints and field issues identified.
• Collaborate with Operations, R&D, Quality Assurance, and Customer Service to determine cross‑functional evaluation, investigation, and solutions.
• Represent Post‑Market Surveillance and Product Quality Engineering in escalations and urgent issues being addressed at a cross‑functional or divisional level.
• Reviews and provides functional approval for project and quality system documentation.
• Develops members of the team and implements process improvements within the Post‑Market Surveillance team.

Education

Bachelor’s degree

Job description

Lead, Quality Engineer

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, 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 This position will be based 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 the Lead Quality Engineer, you will be responsible for owning complex investigations associated with trends and emerging issues associated with product complaints, captured in the CAPA system. This role requires a strong technical understanding of the product, investigation methods, and can work closely cross-functionally to identify root cause of trends and emerging issues to ensure timely and effective investigations and corresponding corrective actions where applicable.

What You’ll Work On

• Isolate root causes and implement effective solutions by means of sophisticated analysis and investigative techniques for product issues.
• Responsible for establishing ADC investigation and reporting methodology as pertaining to elevated complaints and field issues identified.
• Collaborate with Operations, R&D, Quality Assurance, and Customer Service to determine cross‑functional evaluation, investigation, and solutions.
• Represent Post‑Market Surveillance and Product Quality Engineering in escalations and urgent issues being addressed at a cross‑functional or divisional level.
• Reviews and provides functional approval for project and quality system documentation.
• Develops members of the team and implements process improvements within the Post‑Market Surveillance team.

Required Qualifications

Bachelor’s degree with a minimum of 8 years of experience in Quality Assurance or a related field required. An equivalent combination of education and experience, including a minimum of 12 years of relevant experience, will also be considered. Demonstrated initiative and problem‑solving skills; critical‑thinking skills, preferably in a CAPA environment. Experience working cross‑functionally in an investigative role in a Quality management system.

Preferred Qualifications

Quality Assurance and healthcare industry disciplines preferred. Minimum 4 years overall quality experience in an FDA/ISO regulated environment preferred.

The base pay for this position is $100,000.00 – $200,000.00

JOB FAMILY: Operations Quality

DIVISION: ADC Diabetes Care

LOCATION: United States > Alameda : 1360-1380 South Loop Road

ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Not specified MEDICAL SURVEILLANCE: Not Applicable SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day), Continuous standing 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.

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

EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf

Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it’s next‑generation diagnostics, life‑changing devices, science‑based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health. The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well‑being of millions of people. They push the boundaries to help manage and treat some of life’s greatest health challenges. We invite you to explore opportunities at Abbott, to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.