SunnyvaleFull TimeEngineering
Remotely
Listed on 2 job boards, which is a stronger signal than one board alone.
data analysisrisk assessmentroot cause analysisqmsisocapagmpfda
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Job Description
📋 Description
- Own quality projects and investigations within the Endoluminal product platform across design
- Escalation owner for low to medium impact quality risks.
- Review and maintain test records and reports for completeness and accuracy.
- Drive CAPA and systemic non-conformances and contribute to QMS updates.
- Lead risk assessments and process reviews; analyze defect trends and report findings.
- Ensure compliance with GMP, ISO, and FDA standards; collaborate with project Core Teams.
🎯 Requirements
- Minimum 5 years of QE/QA experience; bachelor’s degree in engineering or related field (or
- Solid quality principles and methodologies; strong data analysis and interpretation.
- Ability to identify and resolve quality issues independently; strong communication and teamwork.
- Stay updated with evolving standards, tools, and technologies.
- Willingness to travel <10% and perform frequent computer and inspection work; occasional lifting
🎁 Benefits
- Equal Opportunity Employer; committed to fair employment practices.
- Vaccination or other regulatory requirements may apply depending on role and location.
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