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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 portfolio includes innovative technologies across diagnostics, medical devices, nutrition, and branded generic medicines. With a workforce of 114,000 professionals, we are committed to serving communities in over 160 countries.

Working at Abbott
At Abbott, you will engage in meaningful work, pursue personal and professional growth, and enjoy a supportive environment that values your individuality and well-being.

Benefits
We offer a range of benefits to support your career development and personal needs, including:
  • Career advancement opportunities within a global organization.
  • Comprehensive medical coverage for employees through the Health Investment Plan (HIP) PPO.
  • A robust retirement savings plan with significant employer contributions.
  • Tuition reimbursement and educational benefits to support your pursuit of higher education.

About the Role
This position is based in the Diabetes Care division, where we focus on empowering individuals with diabetes through advanced monitoring solutions. As the Manager of Product Quality Engineering for Complaints, you will lead a team responsible for initiating and managing investigations related to product complaints identified in the CAPA system.

Key Responsibilities
  • Develop and guide Product Quality Engineering teams to identify root causes and implement effective solutions through advanced analysis and investigative techniques.
  • Ensure robust oversight of new product development to facilitate post-market surveillance capabilities at launch.
  • Establish and maintain investigation and reporting methodologies for elevated complaints and field issues.
  • Collaborate with cross-functional teams, including Operations, R&D, Quality Assurance, and Customer Service, to evaluate and resolve product issues.
  • Represent the Complaint Handling and Product Quality Engineering teams in escalations and urgent matters at a divisional level.
  • Review and approve project and quality system documentation to ensure compliance and effectiveness.

Qualifications
Applicants should possess a Bachelor's Degree and a minimum of 6 years of relevant experience, including at least 4 years in a quality role within an FDA/ISO regulated environment. Preferred qualifications include experience in Quality Assurance and healthcare disciplines, as well as demonstrated leadership and problem-solving skills in a CAPA context.

Abbott is an Equal Opportunity Employer, committed to fostering a diverse workforce. We invite you to explore a career with us, where you can build a fulfilling future.