Nonproduct SWQA Lead at Abbott

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 114000 colleagues serve people in more than 160 countries. JOB DESCRIPTION:Working at AbbottAt 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. Youll also have access to:Career development with an international company where you can grow the career you dream of.Employees can qualify forfree medical coverage in ourHealth Investment Plan (HIP) PPOmedical plan in the next calendar year.An excellent retirement savings plan with a high employer contributionTuition reimbursement the Freedom 2 Save student debt program and FreeU education benefit - an affordable and convenient path to getting a bachelors 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 This position works out of our Alameda CA location in the Lingo Division.Meet Lingo a new biosensing technology that provides users a window into their body. Lingo tracks key biomarkers such as glucose ketones and lactate to help people make better decisions about their health and nutrition. Biowearable technology will digitize decentralize and democratize healthcare enabling consumers to take control of their own health. Personalized healthcare is the future. Working on Lingo you will help build a next-generation technology that enables individuals to make decisions about how to improve energy lose weight or enhance athletic performance. The Lingo team embodies a start-up culture and mindset with the backing of Abbott a company with a rich history of healthcare innovation. Join us and grow your career as you help Abbott shape the future of healthcare.This Nonproduct SWQA Lead is responsible for ensuring that computerized systems used in the support of the Quality System are developed validated and maintained in compliance with regulatory and corporate requirements. They help to organize and maintain an inventory of software computerized systems and tools in use to ensure they are in a continued state of validation. They are a key contributor to validation efforts by reviewing quality system documentation as they apply to the development verification validation use and maintenance of the software or firmware. They independently coordinate activities with other functions departments and contractors to complete validation activities. They may also train and direct work of contractors to see projects through to completion What Youll Work OnProvide Quality leadership in direct support of implementation and maintenance of the nonproduct software lifecycles.Lead oversee or contribute to multiple portions of the Quality System including but not limited to Master Validation Plans Impact Assessments Validation Plans System Specifications Requirements Test Protocols Test Reports Trace Matrices Summary reports NC/CAPA and others as needed.Completes SWQA tasks in accordance with current Quality System Requirements.Works independently with objectives given by manager planning and coordinating own work and work of others to high-level project schedulesReviews pre-defined deliverables/activities as identified in the SWQA Non-Product Quality Process Company Policies or project plans.Maintains schedules and drive to meet SWQA schedule as aligned with project(s) goals.Report unexpected events issues or software bugs which occur during verification/validation to project team and management.Develops and maintains departmental operating procedures to ensure compliance to relevant FDA QSR ISO guidelines 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.Ensures that appropriate procedures controls and disaster recovery plans are incorporated into new computerized systems.Coordinates and directs activities of contract personnel as needed to ensure projects come to fruition in a timely manner.Required QualificationsBachelors Degree preferably in Engineering Technical Field Life Science or related discipline or an equivalent combination of education and work experience.6 years experience in a Quality Assurance or software validation experience in a medical device companyKnowledge of FDA QSR ISO13485 ISO14971 and IEC62304Preferred QualificationsKnowledge of Jira Confluence ALM Quality Center and/or other software development and test tools is a plus.ASQ Certifications a plus.Learn more about our health and wellness benefits which provide the security to help you and your family live full lives: 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 on Facebook at and on Twitter @AbbottNews. The base pay for this position is $98000.00 $196000.00In specific locations the pay range may vary from the range posted. JOB FAMILY:Operations Quality DIVISION:LNGO Lingo LOCATION:United States > Alameda : 2901 Harbor Bay Parkway ADDITIONAL LOCATIONS: WORK SHIFT:Standard TRAVEL:Yes 5 % of the Time MEDICAL SURVEILLANCE:Not Applicable SIGNIFICANT WORK ACTIVITIES:Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day) Keyboard use (greater or equal to 50% of the workday) Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans. EEO is the Law link - English: EEO is the Law link - Espanol: Key Skills Administrative Skills,Facilities Management,Biotechnology,Creative Production,Design And Estimation,Architecture Employment Type : Full-Time Experience: years Vacancy: 1 Monthly Salary Salary: 98000 - 196000