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Associate Quality Engineer

Company: Accentuate Staffing
Location: Durham
Posted on: September 25, 2022

Job Description:

Accentuate Staffing is working with a growing medical device manufacturer in the RTP area. The position is responsible for providing quality engineering support to the management and maintenance of all Quality Systems elements to meet the company's business needs, developing company best practices, standards, continuous improvement and ensuring compliance with regulatory requirements and standards. Responsibilities:Assist with supporting tracking and closure of nonconformance, CAPA and change notifications.Provide quality engineering support to assist with supply chain (supplier quality), complaint handling and design control related issues.Provide data for quality metrics, and root cause analysis for various projects.Requirements:Minimum 1 - 4 years' experience in quality engineering role in the diagnostics or medical device industry and BA/BS degree in science, engineering or related technical field; or equivalent combination of skills and experience.Working knowledge of: CAPA, non-conforming product investigations, deviations, change control, training and document control, complaint investigation, field actions and risk assessments, as it relates to batch record release.Preferred: Experience participating in internal and external audits (e.g., FDA, Notified Body, Supplier).Knowledge of ISO 13485:2016 and 21 CRF Part 820 desired.Must have a "hands-on" approach and work effectively on cross-functional teams to establish and maintain appropriate processes pertaining to Quality.Ability to write and review SOPs, Forms and Work Instructions is desired.Ability to demonstrate working knowledge of current and applicable GMP regulations e.g.: ISO 13485:2016 / 21 CFR Part 820.Proficiency on a PC and experience with Microsoft Office Products.Knowledge of validation, statistical process controls, and regulatory compliance preferred but not required.

Keywords: Accentuate Staffing, Durham , Associate Quality Engineer, Engineering , Durham, North Carolina

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