Non-Product Software Quality - Manager
Non-Product Software Quality - Manager
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$ 112000 - 224000
1 Vacancy
Job Description
JOB DESCRIPTION:
Sr. Software QA Manager (Non-Product)
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. Youll 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 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 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
As a senior member of the Quality team ensure that non-product computerized systems used in the support of the Quality System are developed validated and maintained in compliance with regulatory and corporate requirements.
Provide software quality engineering expertise to investigate audit analyze propose improvements and manage processes in the Quality Management Systems as related to non-product initiatives. Identify and implement initiatives for continuous improvement. Author change and update non-product software quality 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 13485 and FDA 21 CFR part 820 and IVD/MDD directives). Will manage and serve as primary contact for all other non-product software quality team members with regards to all non-product software quality assurance activities. 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.
This position is based out of our Alameda CA location and will require being onsite Monday-Friday.
What Youll Work On
- Responsible for the management and daily activities of the non-product 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 non-product computerized systems used in the support of the Quality System and validation activities.
- Works independently with objectives given by Quality management.
- Considered non-product SWQA lead for multiple non-product initiatives.
- Responsible for ensuring accuracy clarity consistency completeness and compliance for multiple projects.
- Completes and ensures non-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 non-product processes in the development of software and software systems.
- Reviews and provides lead guidance to the team regarding deliverables/activities as identified in the 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.
- 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.
- Develop and maintain Validation Master Plan(s).
- Maintains schedule and drive to meet project 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.
- Considered SWQA compliance non-product SME in support of external/internal audits.
Accountability:
- Accountable for the non-product software Quality deliverables and activities in the development of software/firmware products and mobile applications.
- Accountable for compliance with current on-product Software/SWQA/Abbott Corporate policies and requirements in the development of software/firmware products and mobile applications.
- May be called upon to assist in audits as a SME for software quality.
Required Qualifications
- Bachelors 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.
- Must have 8 to 10 years 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.
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 ngersticks.
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
$112000.00 $224000.00In specific locations the pay range may vary from the range posted.
JOB FAMILY:
Operations Quality
DIVISION:
ADC Diabetes Care
LOCATION:
United States > Alameda : 2901 Harbor Bay Parkway
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Yes 10 % of the Time
MEDICAL SURVEILLANCE:
No
SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day) Continuous standing 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: Experience:
Manager
Employment Type
Full-Time
Key Skills
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