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Alchemy are currently partnering with a global technology firm who are looking to recruit a Quality Engineer to be based onsite a client site in Irvine CA.
- 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.
- Degree in Mechanical, Materials or Biomedical Engineering with minimum 2 years of experience.