Manager, Quality Assurance

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 113,000 colleagues serve people in more than 160 countries.

Manager, Quality Assurance

Carlsbad, CA

About Abbott  

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

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.
• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
• 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 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 the best place to work for diverse working mothers, female executives, and scientists.

The Opportunity

This position works out of our Carlsbad, CA location in the Cardiometabolic and Informatics. Our rapid diagnostics solutions are helping address some of the world’s greatest healthcare challenges.  

As the Manager of Quality Assurance, you’ll have the chance to Leads the 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 product and to facilitate compliance with regulatory requirements.

What You’ll Work On

• 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 and independent action through critical decision-making.
• Provides manufacturing support by defining work assignments directed to address manufacturing process defects and implement process improvements utilizing Quality System tools.
• May also direct work assignments for quality control auditors.
• Directs Quality personnel to support new product development by defining projects focused on new products/process development based on coordination with management, project leaders, & design engineers.
• 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 on quality system issues and by delegating project work for maintaining quality system capability.
• Influence/Leadership:
  • Promotes the attainment of group goals by selecting, motivating, and training capable staff;
  • Provides leadership to assigned units by communicating and providing guidance toward achieving group objectives.
• Planning/Organization:
  • 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;
  • Generally makes day-to-day decisions within established guidelines regarding work processes or schedules 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 the substantial expenditure of time, human resources, and funds, without jeopardizing future business activity.

Pay and Shift

The salary range for this position is [$130,000 - $145,000] based on experience.

Required Qualifications

• BS Degree or an equivalent combination of education and work experience
• 7 yrs of Quality Assurance Experience
• People Manager, management of small to medium size teams ( 4-8 direct reports)
• Full cycle experience with Document Control
• Full cycle experience with Change Management
• Full cycle experience with Non-Conformance
• Full cycle experience with CAPAs

Preferred Qualifications

• Chemistry or Biology background
• Biotechn, IVD, or Medical Device industry experience
• Experience working in an R&D environment

Apply Now

* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

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, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

Salary : $130,000 - $145,000