Director, Instrument Quality Assurance

JOB DESCRIPTION:

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. Youll 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.
• 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 bachelors 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.

ABOUT ABBOTT DIAGNOSTICS::

The key to successful treatment and full recovery is often fast accurate diagnosis. Abbotts life-changing tests and diagnostic tools provide insights that enable smarter faster decisions and transform the way the world is managing health.

Our pioneering technology spans the world of healthcare operations with medical diagnostic instruments tests automation and informatics solutions for hospitals reference labs blood centers emergency departments physician offices and clinics.

Our location in Irving TX currently has an opportunity for Director Instrument Quality Assurance

WHAT YOULL WORK ON:

Responsible for all aspects of the business unit Quality System worldwide. Leads quality related resources for the entire product life cycle associated with the development production and distribution of products. As member of the leadership team develop and implement multi-year business and quality strategies.

• Responsible for the operations results and continuous improvement of the Quality System.
• Ensures that all systems are operated in accordance with corporate and worldwide regulatory requirements.
• Provides leadership and quality oversight across multiple diagnostic platforms including Immunoassay Clinical Chemistry and Hematology ensuring consistent application of quality standards regulatory compliance and lifecycle excellence across all technologies.
• Elements of the global Quality System include Quality Systems & Compliance Design QA/Document Control CAPA Operations QA and Incoming QA.
• Works with Division and Corporate to ensure alignment with quality policies and programs.
• Responsible for establishing and achieving the short- and long-term goals and objectives for the Quality organization.
• Develops plans to achieve these objectives.
• Serves as the Management Representative for the Quality System.
• Interfaces with the FDA and other regulatory agencies for quality and compliance issues.
• Coaches develops and motivates the organization to build a sustainable pipeline of leaders.
• Acts as a model leader in the organization.
• Ensures the systems necessary to support the effective application and monitoring of the Quality System are implemented.
• Responsible for implementing and maintaining the effectiveness of the Quality System including the resources to support it.
• Accountable for the operations results and continuous improvement of the Quality System.

REQUIRED QUALIFICATIONS:

• Bachelors degree in a related field or an equivalent combination of education and work experience.
• 8 years of experience in leading an organization in quality and/or medical device/pharmaceutical related discipline.
• Knowledge and application of the principles of the Quality System Regulations and other international regulatory requirements governing medical device manufacturing and distribution required.
• Advanced leadership skills. Ability to build and develop a large organization.
• Excellent verbal and written communication skills.

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

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.

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The base pay for this position is

In specific locations the pay range may vary from the range posted.

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Director