Manager Product Quality Engineering, Complaints

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 114,000 colleagues serve people in more than 160 countries.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and 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.

Free medical coverage for employees* via the Health Investment Plan (HIP) PPO

An excellent retirement savings plan with 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 around the world 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 a best place to work for diversity, working mothers, female executives, and scientists.

Interested in learning more about this job Scroll down and find out what skills, experience and educational qualifications are needed.

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 the Manager Product Quality Engineering, Complaints you will be responsible for the group initiating and owning investigations associated with trends and emerging issues associated with product complaints, captured in the CAPA system.

The group also establishes processes and programs to ensure new products are capable for post-market surveillance as defined in the ADC Quality System at the time of launch.

This role requires a strong technical understanding of the product, investigation methods, and the postmarket surveillance space to ensure timely and effective investigations and corresponding corrective actions where applicable.

This role will be expected to oversee and develop a team of individuals with those same skillsets.

What You’ll Work On

• Develop Product Quality Engineering teams to isolate root causes and recommend or implement effective solutions by means of sophisticated analysis, investigative techniques and troubleshooting methods.
• Establish effective team oversight of new product development to ensure post-market surveillance capabilities at time of launch.
• Responsible for establishing ADC investigation and reporting methodology as pertaining to elevated complaints and field issues identified.
• Work with the complaints group and CAPA team to analyze product issues and then conduct investigations to root cause and identify CAs to resolve.
• Collaborate with Operations, R&D, Quality Assurance, and Customer Service to determine cross-functional evaluation, investigation, and solutions.
• Represent Complaint Handling and Product Quality Engineering in escalations and urgent issues being addressed at a crossfunctional or divisional level.
• Reviews and provides functional approval for project and quality system documentation
• Develops and implements

Required Qualifications

Bachelors Degree

6 years of experience both overall and any industry-specific experience needed

Preferred Qualifications

Quality Assurance and healthcare industry disciplines preferred or equivalent combination of education and work experience

Minimum 4 years Overall quality experience in a FDA / ISO regulated environment.

Substantial demonstrated initiative and problem-solving skills; critical-thinking skills, preferably in a CAPA environment

Experience in leading & managing people.

Experience working in an investigative role in a Quality management system, in collaborations with Quality Assurance / with

Operations and R&D.

Apply Now

Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

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.

The base pay for this position is $109,300.00 $218,500.00. In specific locations, the pay range may vary from the range posted.

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