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POST DATE 3/24/2020
END DATE 3/29/2020
San Diego, CA
JOB DESCRIPTIONSECOND SHIFT: 2PM-11PM
DO WORK THAT MATTERS
At Abbott, diverse ideas, perspectives, and expertise allow us to create the life-changing solutions that help people live healthier lives. In 150 countries and with businesses spanning nutrition, diagnostics, medical devices, and branded generic pharmaceuticals, Abbott offers you enormous opportunities to explore your interests and help you achieve your career and personal goals.
We have an exciting opportunity for a QUALITY ENGINEER within our Abbott Rapid Diagnostics business located at San Diego, CA. In this role, you will be responsible for quality engineering Position hours: 2:00 PM 11:00 PM (2nd shift)activities that address product/process changes, product/process quality issues, and compliance issues. You will partner with operations for process improvement and continuous improvement initiatives and perform process audits of the operations areas. This person may be involved in the development of new products and support design control activities.
Abbott Rapid Diagnostics (formerly Alere) is part of Abbotts Diagnostics family of businesses, bringing together exceptional teams of experts and industry leading technologies to support diagnostic testing which provides important information for treatment and management of diseases and other conditions.
* Actively partner with operations to perform process audits to identify and implement improvement initiatives.
* Support the change control process by reviewing proposed changes, performing risk assessments, and assessing the adequacy of verifications and validations.
* Perform root cause analysis of product quality issues. Apply appropriate tools (e.g. statistics, fault tree analysis, etc.). Work with peers to develop corrective actions.
* Perform failure mode analysis on new or existing products. Ensure all reasonable failure modes are identified. Working with peers, develop mitigations for failure modes, and verify the effectiveness of these mitigations.
* Coordinates for both new products/processes and changes to existing products/processes, develop verification and validation plans that assess if requirements are met.
* Oversee the execution of verification and validation plans in conjunction with Quality Validation Engineer.
* Support the QI and CAPA processes by performing investigations and root cause analysis and determining action plans and driving the actions to closure.
* Demonstrates commitment to the development, implementation and effectiveness of site Quality Management System per ISO, FDA, and other regulatory agencies.
* Aware of the impact on quality when performance is not up to standard. Understands the entire scope of device defects that may occur in their area of responsibility, that includes product design, verification, validation, manufacturing, and testing activities.
* Perform other duties and projects as assigned.
* BS/BA degree or equivalent
* Two years experience in a quality role within the biotechnology industry
* Internal / process audit experience
* An engineering or science background
* Experience with root cause analysis, failure mode analysis, verification, and validation
* Statistical tools including basic statistical inference, graphical methods, regression
* Analytical skills (e.g. statistical, risk analysis, engineering analysis)
* Writing and communication skills (e.g. write technical reports, present data analysis)
* Interpersonal skills
* Service orientation
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.
AN EQUAL OPPORTUNITY EMPLOYER, ABBOTT WELCOMES AND ENCOURAGES DIVERSITY IN OUR WORKFORCE.
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