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. **The Opportunity** The Director, Software Quality is responsible for Abbott’s corporate quality policies and strategic programs associated with both product and non-product related software inclusive of design and development, validation and cybersecurity. Products include PC application software, mobile applications, embedded firmware and hardware products for medical monitoring systems, all digital and cloud products across Abbott’s portfolio. This role leads and directs activities associated with quality, regulatory, and compliance areas of Abbott. Responsible for developing a standard interpretation of regulations for Abbott, facilitating policy development and deployment to the divisions. Actively influence regulations through industry groups and other channels. Provide oversight for FDA communications regarding compliance issues. Provide strategic consulting for the division by interfacing directly with the divisions on policy development and deployment. Develop and assess key metrics. Provide senior management with impact of regulatory changes. This individual will provide oversight for the software (digital and embedded), ensuring that the quality system requirements for design, validation and qualification for product development and production are effectively established and maintained to meet regulatory requirements. Work effectively with multiple different divisions and medical device technologies. Relies on extensive experience and judgment to plan and accomplish goals. Performs a variety of tasks. A wide degree of creativity and latitude is expected. **Responsible for:** + Quality assurance activities for software and firmware development for health care products, including both medical and non-medical applications + Quality assurance activities for integrated and connected systems development for health care products **What You’ll Work On** + Provide overall direction and leadership for validation, design and qualification to assure product quality for application software, embedded firmware and hardware products for medical monitoring systems. + Develop, implement and improve quality policies, processes and procedures, automated systems and reporting systems. + Supports continuous product and process improvement through identifying major site quality risks and product quality metrics; leverages metrics to assist in shaping the strategy of the quality engineering department. + Must understand the details of the business areas involved. Possess strong leadership skills, an overall knowledge of healthcare industry regulations, ability to effectively negotiate and strong communication skills. + Provide strategic consulting for programs being developed or implemented. + Facilitate policy development and deployment throughout the corporation. + Work to achieve program standardization between businesses. + Develop and assess metrics for each center. + Lead and facilitate implementation of new regulations. + Train our various businesses on new requirements for compliance. + Standardize approach to implementation of new regulations. + Provide oversight of quality and compliance goals. + Interface directly with the divisions on policy development and deployment + Partner with other Software Subject Matter Experts (SMEs) including direct manger to provide establish and enforce software related requirements across the corporation + Under direction of the manager, supports the hire and retention of a diverse, highly qualified staff and provides ongoing performance feedback. Sets goals which align to department plans and manages the execution of goals through coaching and mentoring. + Develops process mitigation plans and strategies that are designed to mitigate the risks identified through the Risk Management process, including on-market risk evaluation and assessments. Making decisions on whether or not to take action on market to remedy non-conforming product on-market. + Utilizes practical knowledge of software development and familiarity with Software Development Lifecycle (SDLC) experience with Agile/Lean software development lifecycle process + Complies with worldwide regulations, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. + Assure line of communication with Director of Software Quality, Divisional VP QA and Senior Leaders on critical quality issues that may result in potential business interruption. + Assure business continuity in leadership positions and critical roles through talent management planning and development. **Qualifications** + Bachelor’s degree required in engineering, computer science or technical discipline or equivalent experience in software field. + Master’s degree in a software related discipline preferred. + Minimum 7 years in progressive work experience in software related medical device or highly regulated technology industries. + Minimum 7 years prior management experience. + Requires technical background and direct experience of product development activities for software for leading edge medical devices. + Demonstrated experience in working effectively to ensure quality and compliance requirements are designed/built into the products. + Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results. + Ability to work effectively within a team in a fast-paced changing environment. Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. + Ability to travel, including internationally >50% of time. 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