Tech Observer · 2 days ago

Quality Engineer I

Irvine, CA

Contract

Onsite

Entry Level

0+ years exp

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BiotechnologyLife Science

Hiring Manager

Sudarshan Mishra

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Responsibilities

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.

Qualification

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Regulated Industry ExperienceFDA EnvironmentMS OfficeQuality System ComplianceISO 13485Medical DevicesFDA Regulations21 CFR Part 82021 CFR Part 803ISO 13485 Standard