Alchemy are currently partnering with a global technology firm who are looking to recruit a Quality Engineer to be based onsite in Irvine, CA.

Duties:

• Gap Assessment / review on existing change control Process & Documents.
• Test Method Validation / Validation /  Test Method.
• Working independently with the internal and external stakeholders for execution.
• Provides Quality Engineering support for commercial Medical products.
• Applies knowledge of design control principles, statistics, process & systems validation, and quality engineering techniques to positively influence projects and manufacturing.
• Ensures changes to products are developed and manufactured in accordance with applicable industry standards, regulatory requirements, and customer requirements.
• Apply various engineering principles including metallurgy, heat transfer, strength of materials, statics, sterilization, and biocompatibility.
• Utilizes quality tools to include Risk analysis FMEA, statistical techniques including six-sigma and DOE (design of experiments), root case analysis, reading and correcting drawings.
• Navigates complex government regulations to include FDA & QSR requirements and guidance under 21 CFR820, ISO13485 and ISO14971.
• Present technical data to groups within and outside the organization.
• Develops, modifies, applies, and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
• Perform Test Method Validation and Process Validation.
• Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
• Devices and implements methods and procedures for inspecting, testing, and evaluating the precision and accuracy of products and production equipment.
• Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications..