Manager Quality Assurance

Abbott • Alameda, CA

19h • Onsite

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: Working at Abbott At Abbott, you can do work that matters, grow, and learn, care for yourself and your 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. Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year. An excellent retirement savings plan with a 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 worldwide 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 the best place to work for diversity, working mothers, female executives, and scientists. The Opportunity The healthcare landscape has dramatically evolved over the last several years. Consumers expect to have more control over their information and care decisions in a personalized and accessible environment. To be successful in this space, it is imper ative that Abbott creates a best-in-class customer experience through a leading digital ecosystem that is personalized and builds trust across all of Abbott’s channels. Our Diabetes Care division has a pipeline with products that are squarely focused on the consumer. With TTM revenue of >$7B in Q3 2025, Abbott Diabetes Care (ADC) is a global leader in providing life changing technology for the management and treatment of people living with chronic conditions, including Diabetes . This is an onsite opportunity based out of Alameda, CA. What You’ll Work On The Manager, Quality Assurance, leads a team of experienced QA professionals who exercise latitude and independence in their assignments. Often leads one or more sections/functions or a small quality department. Interprets policies, processes and procedures that may affect sections and subordinate work units. Assignments are defined in terms of activities and objectives . Work is reviewed for adequacy in meeting objectives . Interacts frequently with internal personnel and outside representatives at various levels. Routinely operates as a liaison with customers and suppliers in connection to quality systems and compliance issues and ex ecute s strategic decision-making towards solutions Participates and presents at meetings with internal and externals representatives. Interaction typically concerns resolution of operational and scheduling issues. Responsible for managing one or more quality system elements/functions as defined in the site Quality Manual. Implements the quality plan in accordance with the quality objectives/goals and maintains the effectiveness of the quality system. Recommends staffing and other necessary resource requirements needed to achieve business goals and compliance requirements. Resolves project team issues with minimal oversight. Responsible for ensuring that functional areas of responsibility have adequate training programs for adhering to all safety requirements and business EHS goals. Manage the development and implementation of quality goals. Emerging leader that demonstrates strong leadership competencies. Decision making that has impact on work processes and outcomes, that could cause serious delays and considerable expenditure of an additional time, human resources and funds. May define and implement critical p arameters for design control and related systems throughout the product lines. May oversee the Nonconformance and Real-time data management portions of the quality System. May maintain effective Quality Metrics and define and execute activities to resolve decreases in performance. May support NPD at all stages of development and ensure its compliance to FDA and other agencies. May assist R&D in validation of NPS tools.

Requirements

• Bachelor’s degree in s cientific or technical discipline or an equivalent combination of education and work experience
• Minimum 5 years 5-7 years of experience in a quality function or related field.
• 2 years of direct supervisor experience.
• Previous CAPA and/or quality assurance/engineering experience and demonstrated use of quality tools/methodologies.
• Demonstrated, in‑depth knowledge and experience within the discipline
• Recognized Subject Matter Expert with a strong track record of expertise
• Proven leadership competencies with the ability to influence and guide others
• Experience leading cross‑functional initiatives and driving results across teams
• Strong problem‑solving abilities and adaptability in dynamic environments
• Excellent written and verbal communication skills
• Solid organizational skills with the ability to manage multiple priorities
• Effective negotiation skills and the ability to align cross‑functional stakeholders
• Ability to travel approximately 5%, including internationally, as applicable
• Ability to maintain regular and predictable attendance.

Nice To Haves

• ASQ CQT, CQE, CQA certification preferred
• Six Sigma root cause analysis/problem solving training and experience preferred
• Experience working in a broader enterprise/cross-division business unit model preferred
• Masters Degree

Responsibilities

• Leads a team of experienced QA professionals who exercise latitude and independence in their assignments.
• Often leads one or more sections/functions or a small quality department.
• Interprets policies, processes and procedures that may affect sections and subordinate work units.
• Interacts frequently with internal personnel and outside representatives at various levels.
• Routinely operates as a liaison with customers and suppliers in connection to quality systems and compliance issues and ex ecute s strategic decision-making towards solutions
• Participates and presents at meetings with internal and externals representatives.
• Responsible for managing one or more quality system elements/functions as defined in the site Quality Manual.
• Implements the quality plan in accordance with the quality objectives/goals and maintains the effectiveness of the quality system.
• Recommends staffing and other necessary resource requirements needed to achieve business goals and compliance requirements.
• Resolves project team issues with minimal oversight.
• Responsible for ensuring that functional areas of responsibility have adequate training programs for adhering to all safety requirements and business EHS goals.
• Manage the development and implementation of quality goals.
• Emerging leader that demonstrates strong leadership competencies.
• Decision making that has impact on work processes and outcomes, that could cause serious delays and considerable expenditure of an additional time, human resources and funds.
• May define and implement critical p arameters for design control and related systems throughout the product lines.
• May oversee the Nonconformance and Real-time data management portions of the quality System.
• May maintain effective Quality Metrics and define and execute activities to resolve decreases in performance.
• May support NPD at all stages of development and ensure its compliance to FDA and other agencies.
• May assist R&D in validation of NPS tools.

Benefits

• Career development with an international company where you can grow the career you dream of.
• Employees can qualify for free medical coverage in our Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• An excellent retirement savings plan with a 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 worldwide 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 the best place to work for diversity, working mothers, female executives, and scientists.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager