Quality Engineer- Manufacturing

Medical Device Worcester, Massachusetts Boston, Massachusetts


Description

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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