Keywords: Process Validation, Quality Engineer, Medical Device Risk Analysis, medical device exp

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 of existing change control Processes & 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, the 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 cause 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 products.

• 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.