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Quality Engineering Manager for Product Complaints

2 months ago

Alameda, California, United States Abbott Full time
Company Overview

Abbott is a prominent global healthcare organization dedicated to enhancing the quality of life for individuals at every stage. Our extensive range of innovative technologies encompasses diagnostics, medical devices, nutritionals, 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, foster personal growth, and enjoy a supportive environment that encourages authenticity and a fulfilling life.


Benefits
  • Career advancement opportunities within a global organization.
  • Comprehensive medical coverage for employees through the Health Investment Plan (HIP) PPO.
  • Robust retirement savings plan with significant employer contributions.
  • Tuition reimbursement and programs to assist with student debt.
  • Acknowledgment as a top employer in various countries and recognized by Fortune as one of the most admired companies.
  • Celebrated for diversity and inclusion in the workplace.

Position Overview

This role is situated within our Diabetes Care division, where we are dedicated to empowering individuals with diabetes to manage their health through innovative products that deliver precise data for informed decision-making. As the Manager of Product Quality Engineering, you will spearhead investigations related to product complaints, utilizing the CAPA system.

Your responsibilities will include establishing processes to ensure that new products meet post-market surveillance standards as outlined in the ADC Quality System at launch. A strong technical foundation in product knowledge, investigative methodologies, and post-market surveillance is essential for effective and timely investigations and corrective actions.


Key Responsibilities
  • Lead the Product Quality Engineering teams in identifying root causes and implementing effective solutions through advanced analysis and troubleshooting techniques.
  • Oversee new product development to guarantee post-market surveillance capabilities at launch.
  • Establish investigation and reporting methodologies for elevated complaints and field issues.
  • Collaborate with the complaints group and CAPA team to analyze product concerns and conduct thorough investigations to determine root causes and corrective actions.
  • Work cross-functionally with Operations, R&D, Quality Assurance, and Customer Service to facilitate evaluations, investigations, and solutions.
  • Represent Complaint Handling and Product Quality Engineering in cross-functional escalations and urgent matters.
  • Review and approve project and quality system documentation.
  • Develop and implement quality assurance strategies.

Qualifications

Required: Bachelor's Degree with a minimum of 6 years of experience, including relevant industry experience.

Preferred: Experience in Quality Assurance within the healthcare sector or a comparable combination of education and experience, with at least 4 years in a quality role within an FDA/ISO regulated environment.

Demonstrated initiative, problem-solving capabilities, and critical thinking skills, particularly in a CAPA context. Proven experience in leading and managing teams is essential.

Experience in investigative roles within a Quality Management System, collaborating with Quality Assurance, Operations, and R&D is highly valued.


Compensation

The base salary for this position is competitive, with variations based on location.


Commitment to Diversity

Abbott is an Equal Opportunity Employer, dedicated to fostering employee diversity.