Nonproduct SWQA Lead

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.

JOB DESCRIPTION:

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'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 high employer contribution

• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU 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 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 location in the Lingo Division. 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.

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 You'll Work On

• Provide 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 schedules
• Reviews 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 Qualifications

• Bachelor's 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 company
• Knowledge of FDA QSR, ISO13485, ISO14971 and IEC62304

Preferred Qualifications

• Knowledge of Jira, Confluence, ALM Quality Center, and/or other software development and test tools is a plus.
• ASQ Certifications a plus.

Apply Now

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives:www.abbottbenefits.com

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.

The base pay for this position is
$98,000.00 - $196,000.00
In 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:
Not specified

MEDICAL SURVEILLANCE:
Not Applicable

SIGNIFICANT WORK ACTIVITIES:
Awkward/forceful/repetitive (arms above shoulder, bent wrists), 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), Lift, carry, push or pull weights of more than 20 pounds/9 kilos on a regular/daily basis

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

EEO is the Law link - English: http://webstorage.abbott.com/common/External/EEO_English.pdf

EEO is the Law link - Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf