Quality Engineering Manager

2 weeks 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 diverse portfolio includes innovative technologies across diagnostics, medical devices, nutritionals, and branded generic medicines, supported by a workforce of 114,000 professionals 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 authenticity and well-being.

Benefits
Employees benefit from:
  • Career advancement opportunities within a global organization.
  • Comprehensive medical coverage through the Health Investment Plan (HIP) PPO.
  • A robust retirement savings plan with significant employer contributions.
  • Tuition reimbursement and programs to assist with student debt.
  • A workplace recognized for its commitment to diversity and inclusion.

Position Overview
This role is situated within the Diabetes Care division, focusing on innovative solutions for diabetes management. As the Manager of Product Quality Engineering for Complaints, you will lead investigations into product complaints, ensuring thorough analysis and resolution of trends and emerging issues documented in the CAPA system.

Key Responsibilities
  • Guide the Product Quality Engineering team in identifying root causes and implementing effective solutions through advanced analytical and investigative techniques.
  • Oversee new product development to guarantee post-market surveillance capabilities at launch.
  • Establish and maintain ADC investigation and reporting methodologies for elevated complaints and field issues.
  • Collaborate with the complaints team and CAPA group to analyze product concerns and conduct root cause investigations.
  • Work cross-functionally with Operations, R&D, Quality Assurance, and Customer Service to develop comprehensive evaluation and resolution strategies.
  • Represent the Complaint Handling and Product Quality Engineering teams in escalated and urgent cross-functional matters.
  • Review and approve project and quality system documentation.
  • Develop and implement quality assurance processes and standards.

Qualifications
Required:
  • Bachelor's Degree.
  • A minimum of 6 years of experience in quality management, with specific experience in FDA/ISO regulated environments.

Preferred:
  • Experience in Quality Assurance within the healthcare sector or equivalent combination of education and experience.
  • At least 4 years of leadership experience in quality management roles.
  • Strong problem-solving and critical-thinking skills, particularly in CAPA environments.

Abbott is an Equal Opportunity Employer, committed to fostering a diverse workforce. Explore a career with Abbott and contribute to our mission of improving health outcomes worldwide.

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