Senior Failure Analysis EngineereTeam • San Jose, CA, United States
Senior Failure Analysis Engineer
eTeam • San Jose, CA, United States
30+ days ago
Job type
- Full-time
Job descriptionMinimum of a Bachelor's degree or equivalent 4+ years of experience is required 21 CFR part 820 and Part 803 and ISO 13485 standard, FDA regulations, Medical device (Class I, II, III)
Job Title : Senior Failure Analysis Engineer
Location : San Jose / CA / 95112
Duration : 06 months
Pay Range : $(74.00 - 79.22) / hr on W2 without benefits
Job Description :
- Execute Failure Investigation of Monarch Systems and / or Software complaints to reduce backlog and stabilize metrics and customer feedback times.
- Inclusive of the following activities : complaint intake, investigation, initiation of customer feedback letters, and file review and closure.
- Proficient in project management, data analysis, root cause analysis, communication, and risk determination
- Ensure compliance with the company's Quality System policies and procedures and applicable external requirements and standards, including FDA, ISO 13485, and other worldwide regulatory agencies as pertaining to medical devices.
- Leads investigations into production and customer-facing quality issues to identify root cause, implement corrective and preventative actions, and monitor effectiveness
- Monitors and analyses product performance of medical devices using a statistical and risk-based approach.
Qualifications :
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Senior Engineer • San Jose, CA, United States