Senior Specialist Quality Assurance

Sr. Specialist Quality Assurance 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

The Sr. Specialist Quality Assurance Engineer will lead complaint investigation activities related to blood glucose meters, sensors, and applications. This is a 5 days/week onsite opportunity based out of Alameda, CA.

What You’ll Work On

• Ensure complaint investigations are conducted in compliance with internal procedures, regulatory standards (e.g., FDA, ISO 13485), and within required timelines.
• Drive and support continuous improvement initiatives aimed at enhancing investigation quality, reducing turnaround times, and increasing operational efficiency.
• Monitor investigation workflows, team performance, and key metrics to identify bottlenecks and implement corrective actions where needed.
• Collaborate with cross-functional teams, including R&D, Manufacturing, Regulatory, and Global QA, to drive resolution of systemic product or process issues.
• Participate in internal audits, inspections, and management reviews as the subject matter expert for complaint investigations.
• Maintain compliance with applicable Corporate and Divisional policies and perform additional duties as assigned by management.

Required Qualifications

• Bachelor’s degree in Life Sciences, Engineering, or a related discipline.
• Minimum of 5 years of experience in Quality or a related field. Candidates with an advanced degree (Master’s or Ph.D.) may qualify with less experience.
• An equivalent combination of education and relevant work experience will also be considered.

Preferred Qualifications

• Prior experience conducting complaint investigations in a regulated environment, with knowledge of FDA/QSR regulations and the ISO 13485 standard.
• Strong verbal and written communication skills with the ability to effectively interact across multiple levels of the organization.
• Advanced computer skills, including experience with statistical analysis, data interpretation, and report writing.
• Ability to multitask, prioritize, and meet deadlines in a fast-paced environment.
• Capability to work independently and make informed decisions regarding whether further investigation is required or if closure is appropriate.
• Excellent organizational skills, attention to detail, and the ability to follow through on tasks.
• Prior experience in the medical device industry is preferred.

Apply Now

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:  www.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 www.abbott.com, on Facebook at www.facebook.com/Abbott, and on Twitter @AbbottNews.

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.

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.

The base pay for this position is $98,000.00 – $196,000.00. In specific locations, the pay range may vary from the range posted.

• quality assurance
• complaint investigation
• regulatory compliance
• fda regulations
• iso 13485
• statistical analysis
• data interpretation
• report writing
• cross-functional collaboration
• continuous improvement
• organizational skills
• attention to detail
• multitasking
• problem solving
• communication skills
• time management
• medical device knowledge
• team performance monitoring
• operational efficiency