Azzur Group
Quality Engineer- Manufacturing
From Discovery to Delivery™, Azzur Group provides the life science community full life-cycle solutions for all their GxP needs. From Azzur Cleanrooms on Demand™ facilities, to our labs, training centers and consulting offices across the nation, Azzur Group helps organizations start, scale, and sustain their growing enterprises. With nearly four decades of service to the life science community, we have become a trusted partner to the world's leading pharmaceutical, biotechnology, medical device, and healthcare companies, as well as their supply chain.

Responsibilities

 Collaborate with manufacturing engineers to develop manufacturing processes, procedures, and production layouts tailored to assemblies, equipment installation, processing, machining, and material handling in medical device manufacturing.  Provide support in spearheading and conducting equipment validations, generating comprehensive reports that include IQ, OQ, PQ, and Test Method Validation.  Contribute to the innovation of manufacturing processes aligned with statistical process control, including the development of relevant techniques to enhance quality standards.  Offer expertise and guidance to engineering teams on design concepts and specification requirements to optimize equipment utilization and manufacturing techniques.  Lead the qualification process for new product supplied materials, ensuring that purchased products and components meet industry standards, regulatory requirements, and customer specifications through thorough qualification procedures.  Ensure rigorous adherence to regulatory and product quality compliance by overseeing processes and procedures within the manufacturing environment.  Assist in maintaining and revising documentation related to manufacturing operations, including work instructions, procedures, SOPs, P&ID flows, and associated change controls within the medical device manufacturing setting. 

Requirements

 Minimum 4 years experience  Working knowledge of statistical data analysis 

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Worcester, MA