Senior Failure Analysis Engineer
Apply NowCompany: eTeam
Location: San Jose, CA 95123
Description:
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:
Qualifications:
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:
- Minimum 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)