Manager, Product Quality Engineering

Abbott (abbottcareers2 board); United States; On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

Free medical coverage

Retirement plan

Tuition reimbursement

Education benefit

Diversity recognition

Job summary

Abbott in Alameda, CA, is seeking a Manager, Product Quality Engineering to lead a team responsible for investigations of product complaints and CAPA activities in the Diabetes Care division. The role focuses on post-market surveillance and ensuring new products are launch-ready from a quality perspective.

You will develop and oversee QA investigations, partner with Operations, R&D, QA and Customer Service, and drive corrective actions when needed.

Qualifications

• Bachelor's degree in a related field.
• 6 years of experience overall and in healthcare/regulated environments.

Responsibilities

• Develop Product Quality Engineering teams to isolate root causes and implement effective solutions using analysis and investigations.
• Establish team oversight of new product development to ensure post-market surveillance at launch.
• Establish ADC investigation and reporting methodologies for elevated complaints and field issues.
• Collaborate with complaints group and CAPA team to analyze product issues and conduct root-cause investigations to identify corrective actions.
• Work with Operations, R&D, QA, and Customer Service for cross-functional evaluation and solutions.
• Represent Complaint Handling and Product Quality Engineering in escalations at cross-functional or divisional levels.
• Review and approve project and quality system documentation.
• Develops and implements improvements.

Skills

Root cause analysis

CAPA investigations

Team leadership

Quality systems

Education

Bachelor's degree

Tools

CAPA system

Job description

Working at Abbott

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 115,000 colleagues serve people in more than 160 countries.

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.

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 Manager, Product Quality Engineering, 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 post market 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 cross-functional 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.

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 C