We work as trusted business partners and always strive to deliver the most value and highest return on investment for our clients. We are highly trained business professionals with strong understanding of clients need. We work closely with the leading staffing trade associations, training, and research organizations to ensure we are knowledgeable of the latest industry trends and technologies.

Mandatory Skills: Higher class Medical Device product Risk Analysis, Risk Management ISO14971, ISO 13485 Medical Device Quality Management system

Responsibilities:

·         Degree in Mechanical, Materials or Biomedical Engineering with minimum 4 years of experience

·         Gap 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.

Thanks and Regards,

Mohammed Ilyas,

PH - 229-264-4029.

All your information will be kept confidential according to EEO guidelines.