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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.

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 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 high employer contribution

• Tuition reimbursement, the Freedom 2 Save (https://www.abbott.com/corpnewsroom/strategy-and-strength/tackling-student-debt-for-our-employees.html) student debt program and FreeU (https://www.abbott.com/corpnewsroom/strategy-and-strength/college-degree-for-free-its-possible-with-freeu.html) 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

This position works out of our Plymouth, MN location in Structural Heart division.

Structural Heart Business Mission:

Our business purpose is to restore health and improve quality of life through the design and provision of device and management solutions for the treatment of structural heart disease.

As the Director, Quality Assurance, you’ll have divisional responsibility for the quality assurance of product development. As a member of the Product Development Management Review Board (PDMRB) oversees product design and design changes. Directs Division Design Quality function (responsible for product development and product changes). Review and implement the quality policies; processes; and procedures related to the Design Control subsystem of the Division Quality System. Review and implement appropriate improvements to support an effective Design Control System that links to the appropriate areas of the Quality System. Responsible for tracking the effectiveness of the product development process and establishing quality improvement goals through internal and external quality metrics. Assures the long term effectiveness of the R&D QA organization and ensure that the needs with respect to product development of the division are met. Manage division-wide quality assurance and quality improvement; including support for product development; design transfer; operations manufacturing; process validation; process control and enhancements; quality metric reporting; supplier qualification; design assurance programs; complaint handling and CAPA programs. Cooperates with external partners to ensure TPM developed products meet the requirements of the Division.

What You’ll Work On

• Responsible for implementing and maintaining the effectiveness of the quality system.

• Division responsibility and tracking metrics of the design control process through development of policies and procedures.

• Member of the Division Product Development Management Review Board (PDMRB). Manage and track Design Control Oversight Review Board for Product Review and Metrics to adhere to Division Design Control policies and practices to ensure a consistent level of quality and compliance throughout the preproduction and post-market life of the product.

• Provides recommendations for improvements to the Design Control policies and practices and/or training of personnel based on regular management review of the effectiveness of the system.

• Chair of the Design Control Oversight Review Board that provides management control of the Design Control Quality System.

• Responsible for implementing and maintaining the quality system including quality policy; planning; organizational structure to support the quality system; and management review of the quality system to determine its effectiveness through metric tracking.

• Responsible for alignment of the Quality System to current regulations. (GMP/ISO; etc.)

• Responsible for developing and maintaining a training and certification program for individuals specializing in Design Quality.

Required Qualifications

• B.S. in in Engineering or within Life Sciences

• Minimum 10 years in Product Development and/or Quality Development Support (R&D and/or Technical Support of on-market products

• Experience should include budgetary responsibility, managing product development and launch process, supervision of multiple groups and teams.

Preferred Qualifications

• In depth knowledge of the technology of the Division product portfolio, the needs and demands of our customers and the markets we serve, and the requirements of the regulatory bodies that govern our Quality System. Operations experience is especially helpful.

• Experience in Operations Quality, Regulatory Compliance, Supplier Quality, and Product Performance are a plus.

Apply Now (https://www.jobs.abbott/us/en)

• 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 (http://www.abbottbenefits.com/pages/candidate.aspx)

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 $147,300.00 – $294,700.00. In specific locations, the pay range may vary from the range posted.

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email corpjat@abbott.com