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

#LR-KR1