Client is only considering candidates located in California and authorized to work on W2 for any employer in USA. Non-local candidates are not eligible.
Job title - Quality Engineer I
Location - Irvine Technology Center (ITC) Irvine, CA 92618
Duration - 12+ months contract- 100% on site role, no remote option
Interview Process: 1 interview onsite in Irvine with HM and one peer
Request# 4979-1
Work schedule - Due to site expansion, client is specifically looking for candidates that have flexibility in their working hours to move into mid-shift hours,: 1-9 p.m. Prior to this, associates will work normal business hours through a training period before transitioning into a mid-shift schedule.
Job Description:
The Quality Engineer is responsible for maintaining quality and control of manufacturing processes and post-market performance of medical devices. Responsibilities include collaborating with internal and external stakeholders to achieve company objectives, leading technical root cause investigations, developing and executing risk-based decisions, resolving and documenting customer complaint and manufacturing investigations, and representing Quality in cross-functional projects.
Job Duties:
Develops and executes plans for quality and control to ensure manufacturing continuity and product conformance.
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. Considers any quality, compliance, customer, and business risks.
Performs hands-on troubleshooting of customer returned devices and manufacturing nonconformities and completes associated technical documentation
Develops tools to communicate complex technical problems and solutions to a variety of audiences within the organization
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.
Minimum Requirements:
Bachelor's degree in Engineering.
2 years of relevant experience in a regulated industry (FDA environment preferred).
Knowledgeable of FDA regulations, 21 CFR part 820 and Part 803 and ISO 13485 standard.