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. **Software Quality, Manager** **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** As a senior member of the Quality team, ensure that SWQA computerized systems used in the support of the Quality System and development of ADC customer-facing products are developed, validated, and maintained in compliance with regulatory and corporate requirements. Provide quality engineering expertise to investigate, audit, analyze, propose improvements, and manage processes in the Quality Management Systems and development of ADC consumer products and mobile applications. Identify and implement initiatives for continuous improvement. Author, change, and update software QA procedures as applicable. Ensure compliance with all applicable Abbott Diabetes Care Quality Management policies and with all applicable regulatory and Abbott corporate requirements (such as ISO 9001/13485, FDA 21 CFR part 820, and IVD/MDD directives). Serve as the primary representative for software quality assurance functions for each Product Development Team assigned. Ensure each quality function is integrated into the Project Team at the appropriate phase and is represented at Phase Reviews. Evaluate complaints, CAPAs, internal audit findings, and customer audit findings, and propose corrective and preventive actions. Analyze, monitor, and report status and issues to upper management on software-related projects. Develop and implement Verification and Validation policies, status reports, and strategies. Review and approve validation protocols/reports. Build and maintain successful cross-functional relationships with internal departments such as R&D, System Engineering, Product Quality, Technical Quality, CAPA, and Regulatory Affairs. **What You’ll Work On** + This is a senior-level position with Quality responsibilities as they apply to the development of medical device software, as well as the mobile applications that support those devices. + Assume Quality Lead responsibilities for the project team for ADC products that incorporate software/firmware into their system, as well as Android/iOS mobile applications. + Work independently with objectives given by Quality management. + Serve as the SWQA lead for multiple SWQA initiatives. Responsible for ensuring accuracy, clarity, consistency, completeness, and compliance for multiple projects. + Complete and ensure SWQA tasks in accordance with current Quality System Requirements. + Plan and coordinate own work and the work of other team members according to higher-level project schedules, including directing contract personnel to ensure projects come to fruition in a timely manner. + Ensure that deliverables and activities follow current Software/SWQA processes in the development of ADC software/firmware products and mobile applications. + Review and provide lead guidance to the team regarding predefined deliverables/activities as identified in the SWQA Product Quality Process and/or SWQA Non-Product Quality Process/project plan or equivalent project plan. This includes System Specifications/Requirements documents, Verification Test Cases, Verification/Validation protocols, Trace Matrices, and Verification/Validation Summary Reports for the Alameda site. + Report unexpected events, issues, or software bugs that occur during verification/validation to the project team and management. Assist subordinate staff in recognizing the same. + Develop and maintain departmental operating procedures to ensure compliance with relevant FDA QSR, ISO guidelines (ISO 13485, ISO 14971), including 21 CFR Part 11 and Abbott Corporate requirements as they relate to the development, verification, validation, and maintenance of computerized systems used in the Quality System as well as those used in the development of ADC software/firmware products. + Collect and analyze quality information/data from various quality systems to make data-driven recommendations and decisions. + Take appropriate action based on trends, communicate/report activities and status as needed for senior management review. + Serve as the Software Quality lead in various phases of the development lifecycle, as well as initiate corrective and/or preventive actions as they apply to software development activities. + Develop and maintain Validation Master Plan(s) as needed. + Maintain schedule and drive to meet SWQA schedule as aligned with project(s) goals. + Estimate, plan, schedule, and review own and others’ work products and be accountable for the quality of those reviews and delivery on schedule. + Be accountable for the software Quality deliverables and activities in the development of ADC software/firmware products and mobile applications. + Ensure compliance with current Software/SWQA/Abbott Corporate policies and requirements in the development of ADC software/firmware products and mobile applications. + Be accountable for the quality of assigned software/mobile application Quality System deliverables and review of those deliverables on schedule. + Serve as the SWQA compliance SME in support of external/internal audits; may be called upon to assist in audits as an SME for software quality. **Required Qualifications** + Bachelor's Degree (± 16 years) or equivalent experience of minimum of 12+ yrs in a scientific, technical, or engineering discipline. + Must be technically strong and have experience leading a test engineering or software quality team. + Minimum 8 years of experience in Software Testing and/or Software Quality Assurance. + Minimum 6 years of project experience in software testing practices, methodologies including Agile, and techniques, preferably in testing medical devices and mobile applications. + Knowledge of FDA QSR, relevant ISO guidelines, and 21 CFR Part 11. Has knowledge of Design Control requirements. + Must have excellent oral and written communication skills. 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. **Divisional Information** Medical Devices General Medical Devices: Our medical devices help more than 10,000 people have healthier hearts, improve quality of life for thousands of people living with chronic pain and movement disorders, and liberate more than 500,000 people with diabetes from routine fingersticks. Diabetes We’re focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We’re revolutionizing the way people monitor their glucose levels with our new sensing technology. The base pay for this position is $112,000.00 – $224,000.00. 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