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. **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 (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 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** The **Director, Design Quality** has division responsibility for the quality assurance of product development. This role oversees product design and design changes. Directs Division Design Quality function in US (responsible for product development and product changes). Reviews and implements the quality policies; processes; and procedures related to the Design Control subsystem of the Division Quality System in US. Reviews and implements 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 US Design QA organization and ensure that the needs with respect to product development of the division are met. Manages 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, design related complaint handling and CAPA in US. **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. + Manage and track Design Control Oversight Review for Product Review and Metrics to adhere to ID Design Control policies and practices to ensure a consistent level of quality and compliance throughout the preproduction and post-market life of the product. + Provide 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. + Provides management control monitoring 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. + Manage human resources: provide direction to staff; approve broad staffing decisions; develop tactics to implement site/division policy; and develop the organization to ensure effectiveness. **Required Qualifications** + Bachelor’s degree in engineering or in life sciences or an equivalent combination of education and work experience + Minimum 7 years in Product Development and/or Quality Development Support (R&D and/or Technical Support of on-market products). + Knowledge of regulations and standards affecting IVDs and Biologics (e.g. QS Regulations, EN 46000). + Experience in Quality Assurance is an important element for a complete understanding of the job responsibilities. + Experience should include budgetary responsibility, managing product development and launch process, supervision of multiple groups and teams. + Knowledge of the Design Control Quality subsystem (QSR 820.30) and experience in product development. + In depth knowledge of the technology of the ID 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. Quality experience is an important element to meet Design Control Regulations. **Preferred Qualifications** + Master’s Degree or advanced degree preferred. + Operations or research/technical experience is desired. Product development and product launch experience is helpful. + Knowledge of advanced methods for Product Development such as Design For Six Sigma and DMAIC methodology are desired. Apply Now (https://www.jobs.abbott/us/en) **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. The base pay for this position is $164,900.00 – $329,700.00. 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