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 109,000 colleagues serve people in more than 160 countries.
A healthy heart is essential to good health. That’s why we’re committed to advancing treatments for people with cardiovascular disease. As a global leader in Cardiac Rhythm Technologies, our breakthrough medical technologies help restore people’s health so they can get back to living their best lives, faster. We focus on innovative technologies that can improve the way doctors treat people with heart arrhythmias, or irregular heartbeats.
Our location in Sylmar, CA, currently has an opportunity for a Software Quality Engineer II. The Quality Engineer II will provide software validation support, perform risk management activities, execute test method validations, and execute design controls.
WHAT YOU’LL DO
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Develops and evaluates software quality process and system standards to ensure compliance with company standards and governmental regulatory requirements.
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Investigates/troubleshoots validation problems for equipment and/or performance processes.
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Conducts statistical analyzes of testing results and process anomalies.
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Ability to understand multiple code languages such as C, Python, C#, Visual Basic, etc.
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Basic understanding of instrumentation use such as Function Generators, Oscilloscopes, Multimeters, etc.
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Writes, reviews, approves and/or executes documentation for new and current validation procedures and technical reports related to equipment, products and/or processes.
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May assist with establishing corporate validation policies.
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Work closely with R&D, clinical, manufacturing and MRI, providing expertise and guidance for verifying and validating new products and processes.
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Provide guidance on defining the validation & verification strategy, including risk management mitigations, verification and validation plans, protocols, and reports.
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Review, analyze and provide recommendations for verification and validation test data.
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Provide guidance on resolving deviations associated with verification and validation activities.
EDUCATION AND EXPERIENCE YOU’LL BRING
Required
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Bachelors of Science in Electrical Engineering, Computer Engineering, Robotics/Automation Engineering, or similar degree required.
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ASQ CQE or CSQE certifications preferred.
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Minimum 2 years of experience in software verification and validation in a regulated environment such as Medical Devices, Pharmaceutical Products or Food Manufacturing.
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Ability to work in a highly matrixed and geographically diverse business environment.
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Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
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Ability to leverage and/or engage others to accomplish projects.
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Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
Multitasks, prioritizes and meets deadlines in timely manner.
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Strong organizational and follow-up skills, as well as attention to detail.
Preferred
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Experience working in a broader enterprise/cross-division business unit model.
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Medical device experience.
WHAT WE OFFER
At Abbott, you can have a good job that can grow into a great career. We offer:
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Training and career development, with onboarding programs for new employees and tuition assistance
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Financial security through competitive compensation, incentives and retirement plans
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Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
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Paid time off
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401(k) retirement savings with a generous company match
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The stability of a company with a record of strong financial performance and history of being actively involved in local communities
Learn more about our benefits that add real value to your life to help you live fully: www.abbottbenefits.com
Follow your career aspirations to Abbott for diverse opportunities with a company that provides the growth and strength to build your future. 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 and @AbbottGlobal.