Senior Director, Technical Quality

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 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 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

The Senior Director, Technical Quality establishes, maintains and improves quality system programs, policies, procedures, compliance and best practices across the Division. Specifically, this position provides Abbott Diabetes Care (ADC) Division Quality leadership for Design Control, Design Transfer to Manufacturing, on market risk assessments and product portfolio risk management. The position ensures support of new product development programs, change to on market products, assessment of risk for all on market products, ensuring design changes are transferred into manufacturing appropriately, including transfer into complaint investigations. The scope of this role applies to all ADC sites. This role directs the following functional areas; Digital (App, Cloud & API), Hardware (readers, meter, connected pens, connected partners products), Non-Product Software and Risk Management. Must work with multiple ADC functions (RA, Ops, R&D, IT all levels up to and including division president).

This leader is responsible for translating the vision for quality assurance into tangible organizational goals that will assure that ADC has policies, processes and procedures in place to ensure that design control, Test method/Analytical validation and software development (product and non-product) activities of ADC, meet applicable quality and regulatory standards, divisional and local requirements. She or he ensures the design and development of new and existing products through the management of an effective Design Control system at the divisional, site and program level. They help ensure the consistency of product through strong document and labelling control, training, software, test method and design validation systems. This individual must utilize problem solving skills with limited guidance/oversight to fit the business and quality needs.  Circumstances may require the incumbent to be creative and motivating, especially when working with teams and influencing others who are not a direct report.

What You’ll Work On

• Establish, implement, maintain and monitor policies and procedures for Product Lifecycle Management in accordance with corporate, division and applicable regulatory requirements with respect to ADC sites and suppliers, including Design Control, Validation, Product Storage, Handling, and Distribution and Post Market Data evaluation.
• Assure line of communication with DVP QA & C and Senior Leaders on critical quality issues that may result in potential business interruption.
• Develop quality strategy to achieve business objectives at the division level while ensuring systems are in compliance with global regulatory requirements, making key decisions on product quality and regulatory conformance issues.
• Ensure Quality Records required for DHF, DMR, Document Control and Training are appropriately implemented as it relates to all areas for Technical Quality & Design Controls.
• Interface with other functional groups to plan and imple