- Bachelor's degree Engineering or related field required
- 10+ years experience as a Quality Engineer medical devices new product launches preferred strong knowledge design controls risk management regulations FDA ISO IEC problem-solving statistical skills quality certifications CQE CSQE Six Sigma are a plus
- Able travel as necessary perform physical tasks equipment testing site visits etc when needed even if remote work occurs most days so candidate must pass pre-employment health screening
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Design Quality Engineer Medical Devices - Santa Clara, CA - SciPro
Description
Job Title: Design Quality Engineer Medical Devices
In this role with Scipro you will be responsible for ensuring all design control activities meet company procedures and global regulatory requirements.
You will lead risk management activities including hazard analysis FMEAs and risk documentation own maintain design control documentation partner with R&D Regulatory Manufacturing Project Management teams ensure quality built into every stage of product development.
Maintain accurate test validation risk records report progress leadership support regulatory submissions investigate root causes correct actions related design issues support complaint investigations nonconformances CAPAs after product launch review approve engineering documents test reports identify opportunities improve product quality reduce costs increase efficiency
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