Senior Quality Manager

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

This position works out of our Temecula, CA location in the Abbott Vascular Division.  Our medical devices help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks.  Abbott Vascular provides innovative, minimally invasive, and cost-effective products for treatment of vascular disease.

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

THIS IS AN ONSITE DAILY ROLE REQUIRED POSITION.  NO RELOCATION ASSISTANCE IS AVAILABLE FOR THIS ROLE.

OPEN TO CONSIDER CANDIDATES AT A LOWER LEVEL.

WHAT YOU'LL DO:

This position provides leadership and guidance of QA activities for global TPMs and/or suppliers; responsible for developing goals, objectives, procedures, policies and systems that are in line with company goals and objectives, mission and vision and FDA/ISO regulations. Daily responsibilities include managing the resolution of supplier quality/process issues, ensuring a continuous supply of high quality components to production and supporting product development to ensure the identification of quality oriented suppliers with capable processes that will manufacture high quality components. Ensures systems are in place to monitor and track department and supplier performance. 

MAIN RESPONSIBILITIES

• Develop and consistently execute a quality strategy for global TPM /Suppliers to assure business objectives are met while assuring compliance to applicable regulatory requirements and Abbott policies.
• Direct the TPM/Supplier QA team to ensure that the commitments of the Quality Agreements are being fulfilled and help facilitate resolution in cases where they are not
• Lead and participate on QA cross-functional teams to support TPMs, including active participation in Business Management Reviews as necessary.
• Support long-range planning efforts for capacity (people, systems).
• Act as the primary quality review and decisions maker for high impact TPM exception documents for impact on product quality, safety, efficacy and impact to the regulatory filing.
• Develop and maintain an appropriate Quality Management Review program and Quality Performance Measurements for TPMs and Suppliers, that identify and address quality, operational, and organizational issues
• Promote continuous improvement, innovation, simplification aligned with business strategy
• Recruits, coaches and develops organizational talent.
• Fosters a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
• Creates an entrepreneurial environment.
• Keeps the organization's vision and values at the forefront of decision making and action.
• Demonstrates effective change leadership.
• Builds strategic partnerships to further departmental and organizational objectives.
• Monitors compliance with company policies and procedures (e.g. compliance with FDA, BSI, EEO regulations, etc.).
• Makes decisions regarding work processes or operational plans and schedules in order to achieve department objectives.
• Develops, monitors and appropriately adjusts the annual budge