Abbott Sr Quality Engineer in Sylmar, California
At Abbott, we're committed to helping people live their best possible life through the power of health. For more than 125 years, we've brought new products and technologies to the world -- in nutrition, diagnostics, medical devices and branded generic pharmaceuticals -- that create more possibilities for more people at all stages of life. Today, 99,000 of us are working to help people live not just longer, but better, in the more than 150 countries we serve.
This is an exciting time to join our Cardiac Arrhythmia and Heart Failure division in Sylmar, CA. This site has been growing quickly due to the success of our life-saving Defibrillator and Pacemaker medical devices. The Senior Quality Engineer will provide software validation support, perform risk management activities, execute test method validations, and execute design controls.
Develops and evaluates software quality process and system standards to ensure compliance with company standards and governmental regulatory requirements.
Investigates/troubleshoots validation problems for equipment and/or performance processes.
Conducts statistical analyzes of testing results and process anomalies.
Ability to understand multiple code languages such as C, Python, C#, Visual Basic, etc…
Basic understanding of instrumentation use such as Function Generators, Oscilloscopes, Multimeters, etc.
Writes, reviews, approves and/or executes documentation for new and current validation procedures and technical reports related to equipment, products and/or processes.
May assist with establishing corporate validation policies.
Work closely with R&D, clinical, manufacturing and MRI, providing expertise and guidance for verifying and validating new products and processes.
Provide guidance on defining the validation & verification strategy, including risk management mitigations, verification and validation plans, protocols, and reports.
Review, analyze and provide recommendations for verification and validation test data.
Provide guidance on resolving deviations associated with verification and validation activities.
Bachelors of Science in Electrical Engineering, Computer Engineering, Robotics/Automation Engineering, or similar degree required.
ASQ CQE or CSQE certifications preferred.
Minimum 7-10 years of experience in software verification and validation in a regulated environment such as Medical Devices, Pharmaceutical Products or Food Manufacturing.
Medical device experience strongly preferred.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email email@example.com