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Sr. Development Quality Engineer5050 Nathan Lane N. Plymouth MN 55442 United States7 months contract with high possibility of extensionPay rate: $60/hrWe are looking for an Sr. Development Quality Engineer to join one of our Fortune 500 client’s projects in Plymouth MN. Includes all levels of education and experience.Required skills:
Bachelor’s degree in Engineering or Technical Field.
Minimum of 5 years of experience in R&D, Process/Manufacturing Engineering, and/or Quality with at least 2 years supporting product development.
Experience in medical devices and associated regulations/standards.
Experience in test method development and validation
Experience in preparing risk assessments, FMEA and other risk documents.
Responsible:
Lead and/or support on-time completion of Design Control deliverables
Support the establishment of objective, measurable, and verifiable product requirements
Support Design Verification and Validation planning & execution, including any cross-functional investigation & resolution activities
Lead Risk Management activities from product concept through commercialization
Support test method development and lead test method validation activities
Support manufacturing process development & qualification for new product and design changes
Support the establishment of component specification definitions, supplied component sampling plan development, and vendor qualifications
Support biocompatibility and sterilization qualifications
Support audits and quality system improvement activities
Support Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and regulatory requirements.
Comply with Abbott, U.S. FDA, EUMDR and other requirements, as applicable.
Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and suppliers.
Education:bachelor’s degree on related fieldInterview process :1 st Round: pre-screen over the Zoom or TeamsWe are looking for the candidate who are eligible to work with any employers without sponsorship .If you’re interested, please click “Apply” button.If you are not available or this job is not a good fit at present, please share the job details with your friends/colleagues and let me know if anyone is interested.
Full-time