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|Job Category :
||Quality Engineer with Medical Devices
||San Diego, CA
|Job Description :
VTekis Consulting LLC provides complete solutions for Staff Agumentation, Recruitment Process Outsourcing, Contract Hiring, Direct Hire and Outsourced Solutions. Our goal is to deliver quality professional services to our clients not just to find someone to do a job, we match the right professional for your staffing needs and earning confidence through the proper assignment of people. This alignment of people and companies allows us to create opportunity. Most importantly, We don’t consider the process complete until we find the perfect fit.
Mandatory Skills: Higher class Medical Device product Risk Analysis, Risk Management ISO14971, ISO 13485 Medical Device Quality Management system
Degree in Mechanical, Materials or Biomedical Engineering with minimum 4 years of experienceGap Assessment / review on existing change control Process & Documents.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.
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PH – 229-264-4029
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