Quality Assurance Manager

Abbott • Alameda, CA

10d • $112,000 - $224,000

About The Position

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 114,000 colleagues serve people in more than 160 countries. JOB DESCRIPTION: Quality Assurance Manager (Bogdanoff) Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to: Career development with an international company where you can grow the career you dream of. Free medical coverage for employees via the Health Investment Plan (HIP) PPO An excellent retirement savings plan with high employer contribution Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree. A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune. A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists. The Opportunity As a Quality Assurance Manager for Complaint Investigations, they will be responsible for sustaining the complaint investigation operation, while developing a team and leading projects to advance the lab for future expectations with regards to compliance, capabilities, and workforce output. This role oversees engineers and leads for direct and indirect labor to sustain complaint investigations, and complaint returns. This role is responsible for establishing an operation that performs consistently to maintain requirements for investigation timeliness, and develop processes for new or updated products, while ensuring ongoing compliance and audit readiness per Abbott's Quality Policies and Global Regulations.

Requirements

• Bachelor’s degree or an equivalent combination of education and work experience.
• Minimum 7 years of experience in a FDA/ISO regulated environment.
• Minimum 5 years of experience in Quality.

Nice To Haves

• Substantial demonstrated initiative and problem-solving skills; critical-thinking skills.
• Experience in leading & managing a large team of people.
• Experience working in process and test method development in a Quality management system, in collaborations with Quality Assurance/ with Operations and R&D

Responsibilities

• Oversee complaint investigation lab output and proficiency by developing strong teams and metrics to foster environment of continuous improvement
• Develop and maintain engineering team to advance investigation techniques for execution by direct labor workforce
• Support CAPA initiatives and ongoing projects to ensure ongoing proficiency in complaint investigations operation
• Represent Complaint Investigations lab for audits, projects, and generally acting as subject matter expert for complaint investigations processes.
• Develop metrics and presentations for Quality System Management reviews and associated requirements to ensure compliance and maintain performance
• Reviews and provides functional approval for project and quality system documentation
• Develops and implements plans, ensures milestones are met and prioritizes resource workload as required to meet commitments
• Measures and reports performance of personnel and process relative to targets

Benefits

• Career development with an international company where you can grow the career you dream of.
• Free medical coverage for employees via the Health Investment Plan (HIP) PPO
• An excellent retirement savings plan with high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Number of Employees: 5,001-10,000 employees