Software Validation Engineer

Note:

candidate will have to relocate to MN on their own in 2-3 weeks.

Pay Rate- $40/hr W2

Contract Term: 24 months with possible extension.

Note:

we do not take visa transfers or sponsor Visa. This is not a C2C / 1099 role.

As a Software Quality Engineer at the Client’s Energy and Component Center (MECC) you will have responsibility for providing comprehensive manufacturing quality support for commercial medical devices within component manufacturing.

• Experience with Software Validation for equipment used in production. Experience using SPC, CAPA, NCMR, PDP processes.
• Working knowledge of Quality System Regulations such as (QSR 21 CFR 820), and ISO 13485:2016.

• Provide support for new product commercial medical device component manufacturing lines.
• Devise and implement methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment.
• Design or specify 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 & specifications.
• Apply knowledge of design control principles, statistics, process & systems validation, & quality engineering techniques to positively influence projects and manufacturing.
• Utilize quality tools to include Risk analysis FMEA, statistical techniques including six-sigma and DOE (design of experiments), root case analysis, reading and correcting drawings.