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 115,000 colleagues serve people in more than 160 countries.

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
• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
• 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

Director, Quality Assurance - Informatics Rapid Diagnostics

The Opportunity

We have an exciting opportunity for a Director, Quality Assurance & Regulatory Affairs to join the Cardiometabolic Business Unit, which is within our Abbott Rapid Diagnostics Division (ARDx), to be based out of our Charlottesville, Virginia location. We are seeking a strong, hands-on, Quality leader for our Informatics group within Rapid Diagnostics. Amidst such exciting change in our business, comes the opportunity for this leader to join us in influencing the greater group toward process improvements operate at our highest potential. This unique opportunity is ideal for an experienced Medical Device and/or Diagnostics industry Quality Leader, who thrives in reestablishing an organization during a period of change.

If you seek a dynamic role where your contributions will pave the way in developing new products, systems, and processes, come work with us!

RESPONSIBILITIES

• Provides global strategic direction and tactical assistance to Abbott Informatics (AI) and support on matters related to regulations, quality systems and quality issues. This job function has accountability for complying with local and global Quality System requirements.
• Provides direction to the AI organization in the development, implementation and maintenance of a Quality System appropriate for the functions performed.
• Conducts Management Review to assess and report on Quality System effectiveness to appropriate personnel.
• Works as a member of the management team to develop and monitor quality objectives.
• Serves as the AI Management Representative for the Quality System; acts as a point of contact providing quality guidance and expertise to employees in quality, operations and marketing.
• Supports development of QA personnel through interaction and training to ensure personnel are informed, and that business interactions and processes comply to applicable laws and regulations.
• As applicable, interfaces with regulatory bodies (e.g. FDA, EU Competent Authorities and Health Canada) and other external auditors.
• Implements Global Standards / Procedures and e-enterprise systems as needed to support the quality system.
• Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
• Understands and is aware of the quality consequences of all jobs at AI, and provides appropriate guidance, approves training and supports a culture of continuous improvement at the AI site.
• Has awareness of defects that may occur in all areas of responsibility at the site, including product design, verification and validation, manufacturing and testing activities, as well as implementation activities at customer sites.
• Supports customer complaint processes, from intake of customer calls through resolution; and ensures appropriate procedures are in place and executed to monitor, address, trend, investigate and resolve customer issues.
• Carries out duties in compliance with established business policies.
• Demonstrates accountability for complying with local and global Quality System requirements.
• Understands and is aware of the quality and consequences that may occur from the improper performance of their specific job. Has awareness of defects that may occur in their area of responsibility, and across the business processes of the organization; including product design, verification and validation, manufacturing and testing activities.
• Accountable for establishing appropriate training for the organization, including QS training and ensuring requirements of applicable regulations are encompassed in local procedures.
• Perform other duties and projects as assigned.

QUALIFICATIONS

• Bachelor’s Degree in a scientific or technical discipline is required. Master’s Degree is preferred.
• 10 -15+ years’ experience in a Quality Management or Operations position in an FDA/ISO regulated industry, medical devices or diagnostics, with a software and instrumentation focus is required.
• Capable of analyzing data to support the development of strategies to effectively manage the action plans that will resolve the issues.
• Flexibility to adapt to changing assignments and ability to effectively prioritize.
• Extensive knowledge of relevant regulations for quality systems and compliance.
• Knowledge of medical device and diagnostics manufacturing and quality system processes.
• Strong analytical skills and the ability to organize work in a logical and thorough manner.
• Knowledge of worldwide Quality Management software solutions and industry best practices.

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.

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