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Quality Engineer - Medical Device Mfg.

Company: Goodwin Recruiting
Location: Fremont
Posted on: April 10, 2021

Job Description:

Experienced Medical Device Quality Engineer needed to support Manufacturing, Supply Chain, and Customer Facing functions on applicable product quality, design control, and risk management processes. Responsibilities: Investigate and analyze system failures, report product quality improvement. Evaluate testing protocols, utilize statistical methods and method testing development Promote ongoing Continuous Improvement activities Provide support of product risk analysis through the instrument development lifecycle. Provide support with corrective action and preventive action system, release test statistical sampling methods, FMEA, and DOE.Qualifications: BS in Engineering, or Science discipline; MS is preferred; 4 years of experience with medical device Familiar with process validation principles, and knowledge of 21 CFR Part 820, ISO 13485, and ISO 14971 Familiar with reliability analysis, test methods, injection molding, and assembly preferred CQE preferredBenefits: Comprehensive benefits package Generous vacation time Base Salary 80K-131K, based on experience

Keywords: Goodwin Recruiting, Fremont , Quality Engineer - Medical Device Mfg., Healthcare , Fremont, California

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