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Abbott
Manager, Product Quality EngineeringAbbott • Alameda, CA, United States
Manager, Product Quality Engineering

Manager, Product Quality Engineering

Abbott • Alameda, CA, United States
5 days ago
Job type
  • Full-time
Job description

Manager, Product Quality Engineering

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.

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.
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Manager, Product Quality Engineering • Alameda, CA, United States

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