Manager, Quality Assurance

Abbott (abbottcareers2 board); United States; On-site; USD 120,000 - 180,000; Full time

Job summary

Abbott is seeking a Manager of Quality Assurance in Temecula, CA. The role leads a team of quality engineers to ensure the manufacture of high-quality products and compliance with regulatory requirements.

This onsite position emphasizes strong leadership and collaboration across functions. The role requires a Bachelor's in Engineering with 9+ years in related QA roles, experience guiding teams, and deep knowledge of FDA/BSI quality systems.

Qualifications

• Bachelor's degree in Engineering and 9+ years of related work experience.
• Leadership experience managing QA teams in manufacturing.
• Strong knowledge of FDA/BSI regulations and quality systems.

Responsibilities

• Leads the team of Quality engineers to support manufacturing and ensure high-quality products.
• Develops staffing plans and coordinates with HR for resource changes.
• Directs projects to ensure regulatory compliance and process improvements.
• Monitors cost, performance, and budgets for the QA area and translates goals into KRAs.
• Interacts with internal and external customers to address quality-related inquiries.

Skills

Quality Assurance

Leadership

Regulatory knowledge

Education

Bachelor's degree in Engineering

Job description

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 122,000 colleagues serve people in more than 160 countries.

Quality Assurance Manager

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 of which you dream.
• 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 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

Our location in Temecula, CA, currently has an opportunity for a Manager, Quality Assurance.

THIS IS AN ONSITE ROLE.

WHAT YOU'LL DO:

Leads the team of Quality engineers to support manufacturing. Directs projects to ensure the manufacture of high quality product and to facilitate compliance with regulatory requirements.

Main Responsibilities:

• Implements a staffing plan by identifying resource requirements, writing justifications for additional personnel, obtaining approval for changes, and coordinating the selection process with Human Resources.
• Develops direct reports by securing appropriate training, assigning progressively challenging tasks, applying progressive disciplinary action as appropriate and conducting formal written and verbal performance reviews.
• Monitors daily work operations and provides direction and guidance to, experienced exempt employees, or skilled nonexempt staff to achieve unit or project goals.
• Interacts with internal and external customers, by meeting regularly, responding to requests and explaining procedures.
• Interprets and executes policies that affect work processes and personnel within the assigned organizational unit.
• Contributes to the development of operational policies and procedures that affect personnel within the assigned organizational unit.
• Monitors compliance with company policies and procedures (e.g. compliance with FDA, BSI, EEO regulations etc).
• Contributes to the development and monitoring of area budgets through regular analysis of cost and spending.
• Translates department goals into individual objectives and KRAs.
• Identifies, develops and implements processes to improve department performance.
• Monitors departmental activities and records to ensure compliance independent action through critical decision making.
• Provides supplier development support by defining work assignments directed to address manufacturing process defects and implement process improvements utilizing Quality System tools.
• Implements improvements to Quality Systems and tools by directing personnel to gather data on existing quality tools, identify weaknesses, and research/select new tools based on findings.
• Ensures sustaining support of Quality System and regulatory compliance by individually working quality system issues and by delegating project work for maintaining quality system capability.

EDUCATION AND EXPERIENCE YOU'LL BRING:

• Bachelor's degree (preferably Engineering) and 9+ years of related work experience or an equivalent combination of education and work experience. Advanced degree preferred.
• Promotes the attainment of group goals by selecting, motivating, and training capable staff.
• Provides leadership to assigned units by communicating and providing guidance towards achieving group objectives.
• Schedules human and material resources within a group or section in conjunction with near‑term plans to ensure their availability.
• Carries out operations within an established budget.

Decision Making/Impact:

Assignments are expressed in the form of tasks and objectives; Makes day‑to‑day decisions within established guidelines regarding work processes or schedules in order to achieve the program objectives established by senior management; consequences of erroneous decisions would normally result in serious delays to assigned projects or operations with substantial expenditure of time, human resources, and funds, without jeopardizing future business activity.

Technical/Business Knowledge (Job Skills):

Monitors progress of exempt individuals, teams, supervisors or nonexempt technical individuals toward departmental goals; monitors costs of