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Quality Engineer II

Job

NewAgeSys Inc

Irvine, CA (In Person)

Full-Time

Posted 2 days ago (Updated 14 hours ago) • Actively hiring

Expires 7/22/2026

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Job Description

Req# 10633-1
Req Number:
10633-1
Req Title:
Quality Engineer II
Client:
A Major Pharma Company
Work Address:
Irvine, CA
Req Release Date:
06/18/2026
Duration:
12 months Hours a week: 40 Hours Position Summary 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.
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.
Qualifications:
Minimum Requirements:
Bachelor's degree in Engineering. 3 years of relevant experience in a regulated industry (manufacturing, medical device, or medical device manufacturing preferred). Knowledgeable of FDA regulations, 21 CFR part 820 and Part 803 and
ISO 13485
standard.