Quality Engineer II

Join Our Team as a Quality Engineer in Irvine, CA

Are you passionate about ensuring the highest quality standards in the medical device industry? We are seeking a dedicated Quality Engineer to join our team in Irvine, CA. In this role, you will play a crucial part in maintaining quality and control of manufacturing processes and post-market performance of medical devices. Collaborate with internal and external stakeholders to drive company objectives and lead technical investigations.

Job Responsibilities

• Develop and execute quality control plans to ensure manufacturing continuity and product conformance.
• Lead investigations into quality issues, identify root causes, and implement corrective actions.
• Monitor and analyze product performance using statistical and risk-based approaches.
• Troubleshoot customer returns and manufacturing nonconformities, completing necessary documentation.
• Develop communication tools for complex technical problems and solutions.
• Ensure compliance with company policies and external regulatory standards, including FDA and ISO 13485.

Requirements

• Bachelor's degree in Engineering.
• 3 years of relevant experience in a regulated industry (manufacturing, medical device, or medical device manufacturing preferred).
• Knowledge of FDA regulations, 21 CFR part 820 and Part 803, and ISO 13485 standards.

Preferences

• Proficiency in project management, data analysis, root cause analysis, and risk determination.

Ready to make an impact in the medical device industry? Apply now to join our team in Irvine, CA, and contribute to advancing healthcare quality and safety!

Subject Line: Exciting Opportunity for Quality Engineer in Irvine, CA

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