Job Title

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.

As the Manager, Quality Assurance, you will lead the team of Quality supervisors and Quality Control personnel to support Manufacturing, Supplier Development, New Product Development, Distribution/Warehouse Value Added Services, and Quality Systems. You will directs projects to ensure the manufacture of high quality product and to facilitate compliance with regulatory requirements.
 

What You'll Work On

• Implement a staffing plan 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 appropriate and conducting formal written and verbal performance reviews.
• Monitor daily work operations and provides 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 executes policies that affect work processes and personnel within the assigned organizational unit.
• Contribute to the development of operational policies and procedures that affect personnel within the assigned organizational unit.
• Monitor compliance with company policies and procedures (e.g. compliance with FDA, BSI, EEO regulations etc).
• Contribute to the development and monitoring of area budgets through regular analysis of cost and spending.
• Translate department goals into individual objectives and KRAs.
• Identifies, develop and implement processes to improve department performance.
• Monitor departmental activities and records to ensure compliance independent action through critical decision making.
• Provide 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.
• Direct 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.
• 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 individually working quality system issues and by delegating project work for maintaining quality system capability.
• Promote the attainment of group goals by selecting, motivating, and training capable staff.
• Provide leadership to assigned units by communicating and providing guidance towards 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.
• Assignments are expressed in the form of tasks and objectives.
• Generally make 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.

Required Qualifications

• Bachelor's Degree or an equivalent combination of education and work experience
• 8-10 years roles of increasing responsibility, impact, and scope within a manufacturing support environment in quality desired.
• 3-5 years in a supervisory/leadership role.
• Class III or II medical device experience.
• Demonstrated performance and results nonconformance management and reduction, value improvement, risk reduction, and cost containment.
• Ability to travel internationally to support international manufacturing sites.
• Demonstrated and impactful experience in process improvement (KPIV, KPOV, Fishbone, Is/Is Not, QFD), Six Sigma, product and process qualification and validation, Process Control & Monitoring (SPC).
• Demonstrated and impactful strong project management and people leadership skills required.
• Experience working in a broader enterprise/cross division business unit model preferred.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results.
• Ability to work effectively within a team in a fast-paced changing environment.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Multi-tasks, prioritizes and meets deadlines in timely manner.
• Strong organizational, planning, and follow-up skills and ability to hold others accountable.
• Ability to travel approximately 25%, including internationally. ​

Preferred Qualifications

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.

The base pay for this position is $99,300.00 – $198,700.00. In specific locations, the pay range may vary from the range posted.