Quality Engineer- Manufacturing - Worcester, United States - Azzur Group

Description

From Discovery to DeliveryTM, Azzur Group provides the life science community full life-cycle solutions for all their GxP needs. From Azzur Cleanrooms on DemandTM 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.

• Minimum 4 years experience
• Working knowledge of statistical data analysis