Quality Engineer I

Job Description

Job Title Quality Engineer I
Location lton Parkway, Irvine CA 92618
Duration 12 Months

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.

• 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.
• Product performance of medical devices using a statistical and risk-based approach. Considers any quality, compliance, customer, and business risks.
• Monitors and Performs hands-on troubleshooting of customer returned devices and manufacturing non-conformities 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.

• 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
• Bachelor's degree in Engineering