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Sr. Design Quality Engineer

Employer
The Judge Group
Location
Minneapolis
Salary
Competitive

View more

Location: Minneapolis, MN
Description: Our client is currently seeking a Sr. Design Quality Engineer for a 12 month + contract.

Job Details:In this Senior Design Quality Engineer position, you will be responsible for developing qualification plans, protocols, perform product testing and failure analysis, writing reports. You will make regular use of problem-solving tools and statistical analysis to perform test method development and validation, design verification, risk assessment and design reviews. As a DQE, you will be responsible for product risk management and adherence to design control requirements throughout the product lifecycle. You will create and maintain risk files and assess the impact of necessary changes to our products. This position will start as a remote position and will transition into an on-site position later. Will work within the new product development team and product change team, with responsibilities including, but not limited to the following: ??? Guide teams through our internal quality system to ensure products are developed in compliance to those procedures as well as the requirements of the FDA, ISO, and other regulatory bodies. ??? Review and evaluate project documentation for compliance as well as sound technical competence to ensure we are delivering robust products/processes. ??? Provide input throughout the new product development process and product change process from a quality perspective ??? Provide risk management for project including risk analysis and development of sound mitigation strategies ??? Provide efforts for usability and human factors engineering ??? Collaborate with Design Engineers to develop robust verification test strategies to ensure safe, reliable products are implemented. ??? Support process and product validation programs for new product development ??? May perform supplier development activities surrounding PPAP ??? May have involvement in continuous improvement projects for the organization
What you need Minimum Qualifications: ??? Bachelor's degree in Engineering, Science or similar field ??? 3+ years of experience in engineering, quality, new product development, working in a highly regulated environment
Preferred Qualifications: ??? 2+ years of experience in Medical Device industries ??? European Medical Device Regulation (MDR) process experience ??? Experience in Design Control, Risk Management, and Statistical Analysis ??? Experience in Human Factors/Usability Engineering desired
Contact:
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