Lead Design Quality Engineer - Software Validation

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:

Lead Design Quality Engineer - Software Validation

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. 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 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 bachelor's 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
This position works out of our San Diego, CA location in the Rapid and Molecular Diagnostics, Infections Diseases business. Our diagnostic solutions are used in hospitals, laboratories, and clinics around the globe. The crucial information derived from our tests, instruments, and informatics systems is often the first step in patient care decision-making for hundreds of health conditions from heart attacks to blood disorders to infectious diseases and cancers.

As the Lead Design Quality Engineer - Software Validation, you'll reviews documentation for accuracy, clarity, consistency, completeness and compliance for multiple projects. Plans and performs assignments with a wide degree of difficulty. Analyzes data, procedures, and requirements with consideration given to financial and business outcomes. Coordinates activities across impacted groups. Accepts ownership and responsibility for decisions. Effectively engages team members and provides guidance to various functions, other professionals, and technicians.

What You'll Work On

• Reviews pre-defined deliverables/activities as identified in software quality assurance (SWQA) Non-Product Quality Process and/or SWQA Product Quality Process/project plan or equivalent project plan.
• Applies basic risk management principles to all activities and tasks to investigate non-conformances.
• Identifies areas for process improvement and provides supporting information for change, including reasons and justifications.
• Participates or leads in the development or modification of validation packages and deliverables, including, assessments (including risk assessments, e.g., FMEAs), plans, requirements, and protocols.
• Ensure compliance to relevant FDA QSR, ISO guidelines, including 21 CFR Part 11 and Abbott Corporate requirements as they relate to the development, validation and maintenance of computerized systems.
• Assists with supplier assessments and evaluations to assure products and services meet quality requirements.
• May evaluate vendor capabilities to provide required products or services.

Required Qualifications

• Bachelors Degree in Computer Science, software engineering, or closely related discipline, or an equivalent combination of education and work experience.
• Minimum of 7 years related work experience in Quality or related field.

Preferred Qualifications

• Masters degree preferred
• Knowledgeable of FDA, Quality System Regulations (QSR), Medical Device Directive, ISO guidelines and 21 CFR Part 11.
• Project experience in software testing practices, methodologies and techniques, particularly in testing medical devices or experience leading test engineer team is 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: https://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 abbott.com, on LinkedIn at https://www.linkedin.com/company/abbott-/, and on Facebook at https://www.facebook.com/AbbottCareers.

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:
ID Infectious Disease

LOCATION:
United States > San Diego : 4545 Towne Center Court

ADDITIONAL LOCATIONS:

WORK SHIFT:
Standard

TRAVEL:
Yes, 20 % of the Time

MEDICAL SURVEILLANCE:
Not Applicable

SIGNIFICANT WORK ACTIVITIES:
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