Compliance Quality Software Lead

JOB DESCRIPTION:

Compliance Quality Software Lead

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. 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 contribution
• Tuition 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

As a Compliance Quality Software Lead your role will include responsibilities such as ensuring 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. You will 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 and FDA 21 CFR part 820 and IVD/MDD directives). Serve as primary representative for software quality assurance functions for each Product Development Team assigned. Ensure each quality function is brought into the Project Team at the appropriate phase and is represented at Phase Reviews. Evaluate complaints CAPAs internal audits findings customer audits 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 department such as R&D System Engineering Product Quality Technical Quality CAPA and Regulatory Affairs.

What Youll Work On

• This is a senior level position with Quality responsibilities as they apply to the develop of medical device software as well as the mobile applications that support those devices.
• Assumes Quality Lead responsibilities of the project team for ADC products that incorporate software/firmware into their system as well as Android/iOS mobile applications.
• Works independently with objectives given by Quality management.
• Considered SWQA lead for multiple SWQA initiatives. Responsible for ensuring accuracy clarity consistency completeness and compliance for multiple projects.
• Completes and ensures 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 Software/SWQA processes in the development of ADC software/firmware products and mobile applications.
• Reviews and provides lead guidance to the team regarding pre-defined deliverables/activities as identified in the SWQA
• Product Quality Process and/or SWQA Non-Product Quality 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 as well as those used in the development of ADC software/firmware products.
• 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.
• May Develop and maintain Validation Master Plan(s).
• Maintains schedule and drive to meet SWQA schedule as aligned with project(s) goals.
• Will also estimate plan schedule and review own and others work products and be accountable for the quality of those reviews and delivery on schedule.
• Accountable for the software Quality deliverables and activities in the development of ADC software/firmware products and mobile applications.

Accountable for compliance with current Software/SWQA/Abbott Corporate policies and requirements in the development of ADC software/firmware products and mobile applications.

• Accountable for the quality of assigned software/mobile application Quality System deliverables and review of those deliverables on schedule.
• Considered SWQA compliance SME in support of external/internal audits; may be called upon to assist in audits as a SME for software quality.

Required Qualifications

• B.S. in a Scientific Technical or Engineering discipline. Combination of work and education will be considered.
• Must be technically strong and have experience leading a test engineering or software quality team.
• 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.
• Minimum 6 years project experience in software testing practices methodologies including Agile and techniques preferably in testing medical devices and mobile applications.
• Minimum 8 years of experience in Software Testing and/or Software Quality Assurance.

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.

Divisional Information

Medical Devices

General Medical Devices:

Our medical devices help more than 10000 people have healthier hearts improve quality of life for thousands of people living with chronic pain and movement disorders and liberate more than 500000 people with diabetes from routine fingersticks.

Diabetes

Were focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. Were revolutionizing the way people monitor their glucose levels with our new sensing technology.

The base pay for this position is

In specific locations the pay range may vary from the range posted.

JOB FAMILY:

DIVISION:

LOCATION:

ADDITIONAL LOCATIONS:

WORK SHIFT:

TRAVEL:

MEDICAL SURVEILLANCE:

SIGNIFICANT WORK ACTIVITIES: