Abbott Senior Quality Engineer in Menlo Park, 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.

Summary:

This is an exciting time to join our Structural Heart division in Menlo Park. This site has been growing quickly due to the success of our life-saving MitraClip medical device. The Senior Quality Engineer will provide Validation support, perform risk management activities, execute test method validations, and execute design controls.

Job Description:

Develop and track validation related metrics.

Provide validation training and consultation services on validation policies and practices.

Work closely with R&D and manufacturing 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.

Qualifications:

Minimum 5 years of experience in design/process 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 corpjat@abbott.com