Senior Design Control, Software Quality Engineer (Medical Devices)

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, CA office and is responsible for ensuring that Abbott and Lingo product software and computerized systems used in the support of the Quality System are developed, validated and maintained in compliance with regulatory and corporate requirements. This is an individual contributor position which may have responsibilities to monitor and direct the work of contractors/temporaries.

What You’ll Work On

• Participates as a member of the project team for Lingo products that incorporate software/firmware into their system.
• Completes SWQA tasks in accordance with current Quality System Requirements.
• Works independently with objectives given by SWQA Manager.
• Can plan and coordinate own work according to higher-level project schedules.
• Reviews pre-defined deliverables/activities as identified in the SWQA Product Quality Process/project plan or equivalent project plan.
• Ensures that deliverables and activities are in compliance with current Software/SWQA processes in the development of Lingo software/firmware products.
• Ensure documentation accuracy, clarity, consistency, completeness and compliance for multiple projects including System Specifications/Requirements documents, Verification Test Cases, Verification/Validation protocols, Trace Matrices and Verification/Validation Summary Reports.
• Report unexpected events, issues or software bugs which occur during verification/validation to project team and management.
• Ensures Device History File (DHF) and Device Master Record (DMR) are in compliance with regulatory standards and quality management policies and procedures.
• 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.
• May Develop and maintain Validation Master Plan(s).

Required Qualifications

• Bachelors degree, or equivalent experience, in a scientific, technical, or engineering discipline.  
• Must have 5+ experience in Software Quality Assurance.
• Knowledge of medical device standards including FDA QSR, ISO 13485, ISO 14971, 21 CFR Part 11 and IEC 62304. In particular, has knowledge of Design Control requirements.
• Must have excellent oral and written communication skills. 

Preferred Qualifications

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

$86,700.00 – $173,300.00

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)

     

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