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: 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)