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Quality Engineering Manager

2 months ago

Alameda, California, United States Abbott Full time
Company Overview

Abbott is a leading global healthcare organization dedicated to enhancing the quality of life for individuals at every stage of their health journey. Our extensive range of innovative technologies encompasses diagnostics, medical devices, nutritionals, and branded generic medicines, serving communities in over 160 countries through our dedicated workforce of 114,000 professionals.


Work Environment

At Abbott, we foster an environment where you can engage in meaningful work, pursue personal and professional growth, and maintain a healthy work-life balance. We prioritize your well-being and encourage you to be your authentic self.


Benefits

As part of our commitment to our employees, we offer:

  • Career advancement opportunities within a globally recognized company.
  • Comprehensive medical coverage for employees through the Health Investment Plan (HIP) PPO.
  • A robust retirement savings plan with significant employer contributions.
  • Tuition reimbursement programs, including the Freedom 2 Save student debt initiative and FreeU education benefits for pursuing a bachelor's degree.

Abbott has been acknowledged as a top employer in numerous countries and is consistently recognized by Fortune as one of the most admired companies globally. We are proud to be celebrated for our commitment to diversity and inclusion in the workplace.


Position Overview

This role is situated within our Diabetes Care division, where we are dedicated to transforming diabetes management through innovative products that deliver precise data for informed decision-making. As the Manager of Product Quality Engineering for Complaints, you will lead a team responsible for initiating and managing investigations related to product complaints documented in the CAPA system.

Your responsibilities will include:

  • Developing Product Quality Engineering teams to identify root causes and implement effective solutions through advanced analysis and investigative techniques.
  • Ensuring that new product development processes are aligned with post-market surveillance requirements at launch.
  • Establishing methodologies for ADC investigations and reporting concerning elevated complaints and field issues.
  • Collaborating with cross-functional teams, including Operations, R&D, Quality Assurance, and Customer Service, to evaluate and resolve product issues.
  • Representing Complaint Handling and Product Quality Engineering in escalations and urgent matters at a divisional level.
  • Reviewing and approving project and quality system documentation.
Qualifications

Required:

  • Bachelor's Degree.
  • A minimum of 6 years of overall experience, including relevant industry experience.

Preferred:

  • Experience in Quality Assurance within the healthcare sector or a comparable combination of education and experience.
  • At least 4 years of quality experience in an FDA/ISO regulated environment.
  • Demonstrated initiative, problem-solving capabilities, and critical-thinking skills, particularly in a CAPA context.
  • Experience in leading and managing teams.
  • Background in investigative roles within a Quality Management System, collaborating with Quality Assurance, Operations, and R&D.

At Abbott, we are committed to fostering a diverse and inclusive workplace. We believe in providing our employees with the resources and support they need to thrive both personally and professionally.