Job Description

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 115,000 colleagues serve people in more than 160 countries.

About Abbott

Abbott is a global healthcare leader, creating breakthrough science to improve people\xe2\x80\x99s health. We\xe2\x80\x99re always looking towards the future, anticipating changes in medical science and technology.

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\xe2\x80\x99ll also have access to:

• Career development with an international company where you can grow the career you dream of.
• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
• An excellent retirement savings plan with high employer contribution
• Tuition reimbursement, the

student debt program and education benefit - an affordable and convenient path to getting a bachelor\xe2\x80\x99s 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

This position works out of our Alameda, CA location in the Abbott Diabetes Care Division, where we are focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. We\xe2\x80\x99re revolutionizing the way people monitor their glucose levels with our new sensing technology.

As a senior member of the Quality team, you will be responsible for ensuring that ADC products are developed, validated and maintained in compliance with regulatory and corporate requirements (Such as, ISO 13485 and FDA 21 CFR part 820, and IVD/MDD directives). You will identify and implement initiatives for continuous improvement and drive quality goals to completion. Mentor and lead other members of the software quality team as well as author, change and update software quality procedures as applicable.

What you\xe2\x80\x99ll work on

• Responsible for the management and daily activities of members of the software quality team reporting directly to the SWQA manager.
• This is a senior level position with Quality management responsibilities as they apply to the develop of ADC products.
• Considered software quality SWQA lead for multiple initiatives. Responsible for ensuring accuracy, clarity, consistency, completeness, and compliance for multiple projects.
• Completes and ensures product SWQA tasks in accordance with current Quality System Requirements.
• Can plan and coordinate own work and work of other team members according to higher-level project schedules. Including direction of contract personnel to ensure projects come to fruition in a timely manner.
• Will ensure that deliverables and activities are following current processes in the development of software and software systems.
• Reviews and provides lead guidance to the team regarding deliverables/activities as identified in the ADC Design Control Process/project plan or equivalent project plan. Including System Specifications/Requirements documents, Verification Test Cases, Verification/Validation protocols, Trace Matrices and Verification/Validation Summary Reports for the Alameda site.
• Reports unexpected events, issues or software bugs which occur during verification/validation to project team and management. Assists subordinate staff in recognizing the same.
• Develops and maintains departmental operating procedures to ensure compliance to 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.
• Collect and analyzes quality information/data from various quality systems to make data driven recommendations and decisions.
• Takes appropriate action based on the trends, communicate/report activities and status as needed for senior management review.
• Software Quality lead in various phases of the development lifecycle, as well as initiation of corrective and/or preventative action as it applies software development activities.
• Maintains schedule and drive to meet project schedule as aligned with project(s) goals.
• Will also estimate, plan, schedule and review own and others\xe2\x80\x99 work products and be accountable for the quality of those reviews and delivery on schedule.
• Considered SWQA compliance SME in support of external/internal audits.

Required Qualifications

• Bachelor\xe2\x80\x99s degree, or equivalent experience, in a scientific, technical, or engineering discipline
• Must be technically strong and have experience leading/managing a test engineering or software quality team.
• Bachelor\xe2\x80\x99s degree, or equivalent experience, in a scientific, technical, or engineering discipline.
• Must have 8 to 10 years\xe2\x80\x99 experience in Software Testing and/or Software Quality Assurance.
• Must have 6 - 8 years 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.

What We Offer

At Abbott, you can have a good job that can grow into a great career. We offer:

• Training and career development, with onboarding programs for new employees and tuition assistance
• Financial security through competitive compensation, incentives and retirement plans
• Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
• Paid time off
• 401(k) retirement savings with a generous company match
• The stability of a company with a record of strong financial performance and history of being actively involved in local communities

Learn more about our benefits that add real value to your life to help you live fully:

Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. Abbott is an Equal Opportunity Employer, committed to employee diversity.

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Abbott