Lead Engineer Quality

Abbott (abbottcareers2 board); United States; On-site; USD 150,000 - 190,000; Full time

Job summary

Abbott in Alameda, CA, Diabetes Care division seeks a Lead Quality Engineer to own complex CAPA investigations and root-cause analysis for product complaints. You will partner with Operations, R&D, QA, and Customer Service to drive timely corrective actions and cross-functional solutions.

The role requires strong product knowledge and experience in a GMP/ISO-regulated environment, with a focus on continuous process improvement within Post-Market Surveillance.

Qualifications

• Bachelor's degree with a minimum of 8 years of experience in Quality Assurance or a related field.
• Equivalent combination of education and experience with at least 12 years will be considered.
• Demonstrated initiative and problem-solving skills; critical-thinking in a CAPA environment.
• Experience working cross-functionally in an investigative role within a Quality management system.

Responsibilities

• Isolate root causes and implement effective solutions using advanced analysis.
• Establish ADC investigation and reporting methodology for elevated complaints.
• Collaborate with Operations, R&D, QA, and Customer Service for cross-functional evaluation.
• Represent Post-Market Surveillance and Product Quality Engineering in escalations.
• Review and approve project and quality system documentation.
• Develop team members and implement process improvements within Post-Market Surveillance.

Skills

Quality Assurance

CAPA investigations

Root cause analysis

Cross-functional collaboration

Education

Bachelor's degree

Tools

CAPA system

Job description

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.

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.

Equal Opportunity Employer

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

Divisional Information

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 Rhythm Technologies, we focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias or irregular heartbeats.

Diabetes: We're 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.

Vascular: Abbott Vascular provides innovative, minimally invasive, and cost-effective produc