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.

Working at Abbott

At Abbott, you can do work that matters, grow, learn, care for yourself and your family, be your true self, and live a whole life. You will also have access to:

• Career development with an international company where you can grow the career you dream of.
• Free medical coverage will be included 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.
• Recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies by Fortune.
• Recognized as one of the best big companies to work for and the best place to work for diverse employees, working parents, female executives, and scientists.

The Opportunity

Abbott Rapid Diagnostics is part of Abbott’s Diagnostics family of businesses. It brings together exceptional teams of experts and industry-leading technologies to support diagnostic testing, which provides important information for the treatment and management of diseases and other conditions.

The position of Manager Quality Assurance is within our Cardiometabolic business based out of Carlsbad, CA.

As a Manager of Quality Assurance, the person would be responsible for leading a team of Quality supervisors/engineers/technicians to support Manufacturing, Supplier Development, New Product Development, Distribution/Warehouse Value Added Services, and Quality Systems. Directs projects to ensure the manufacture of high-quality products and to facilitate compliance with regulatory requirements.

What You’ll Work On

Staffing and Development:

• Implement staffing plans by identifying resource requirements, writing justifications for additional personnel, obtaining approval for changes, and coordinating the selection process with Human Resources.
• Develop direct reports by securing appropriate training, assigning progressively challenging tasks, applying progressive disciplinary action as needed, and conducting formal performance reviews.

Operations and Compliance:

• Monitor daily work operations and provide direction and guidance to experienced exempt employees or skilled nonexempt staff to achieve unit or project goals.
• Interact with internal and external customers by meeting regularly, responding to requests, and explaining procedures.
• Interpret and execute policies affecting work processes and personnel within the assigned organizational unit.
• Contribute to the development of operational policies and procedures affecting personnel within the assigned organizational unit.
• Monitor compliance with company policies and procedures (e.g., FDA, BSI, EEO regulations).

Financial and Performance Management:

• Contribute to the development and monitoring of area budgets through regular analysis of cost and spending.
• Translate department goals into individual objectives and Key Result Areas (KRAs).
• Identify, develop, and implement processes to improve department performance.
• Monitor departmental activities and records to ensure compliance and support independent action through critical decision-making.

Manufacturing and Quality Support:

• Provide manufacturing support by defining work assignments to address manufacturing process defects and implement process improvements using Quality System tools.
• Direct work assignments for quality control auditors as needed.
• Direct Quality personnel to support new product development by defining projects focused on new products/process development in coordination with management, project leaders, and design engineers.
• Implement 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.
• Ensure sustaining support of Quality System and regulatory compliance by working on quality system issues and delegating project work to maintain quality system capability.

Leadership and Planning:

• Promote the attainment of group goals by selecting, motivating, and training capable staff.
• Provide leadership to assigned units by communicating and guiding them toward achieving group objectives.
• Schedule human and material resources within a group or section in conjunction with near-term plans to ensure their availability.
• Carry out operations within an established budget.

Decision Making and Impact:

• Make day-to-day decisions within established guidelines regarding work processes or schedules to achieve program objectives set by senior management.
• Understand that erroneous decisions could result in serious delays to assigned projects or operations, with substantial expenditure of time, human resources, and funds, without jeopardizing future business activity.

Education and Experience You’ll Bring

Required:

• Bachelor’s degree and 9+ years of related work experience or an equivalent combination of education and work experience.
• Experience with:
  • Overseeing the external environment in technical/professional areas.
  • Ensuring compliance with quality system regulations.
  • Developing and improving work processes and resource utilization.
  • Facilitating continuous improvement programs.
  • Solving problems impacting work processes and personnel.
  • Monitoring the progress of individuals and teams toward departmental goals.
  • Managing project costs and resources.

Preferred:

• Advanced degree(s) in the field.
• Previous experience with Agile and METRO.
• Previous experience with ISO 13485

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity. Connect with us at www.abbott.com, Facebook at www.facebook.com/Abbott, and Twitter @AbbottNews.

The base pay for this position is $112,000.00 – $224,000.00. In specific locations, the pay range may vary from the range posted.