Quality Engineer

Iconma, L.L.C. Plymouth , MN 55447

Posted 3 months ago

Quality Engineer

Location: Plymouth, MN

Duration: 1 year

Description:

  • Consult with Manufacturing, Information Management, Research Development & Engineering, Quality Assurance Operations and Product Performance Analysis teams to ensure compliance to LifeScan software development procedures and industry regulations. Review and approve deliverables of the software development lifecycle. Lead teams in performing Hazard Analysis. Occasionally assist teams in developing Standard Operating Procedures and Work Instructions for software development activities that meet their specific needs. Occasionally provide training for select software development activities for LifeScan. Occasionally write and execute test protocols and reports. 0-3 years exp

  • EU MDR: remediate legacy project documents to be EU MDR ready. This specifically involves test method development, test equipment qualification, test method validation, and design verification testing, protocol and report writing

  • ISO 80369-7: the activities will involve design change, design verification testing, test method development, validation, protocol and report writing

  • PMA readiness: the activities will involve reviewing and remediate existing design controls documentation to be PMA submission and audit ready

  • The individual have to be able to multi-task, work independently, pay attention to details, and keep up with the project timeline

As an equal opportunity employer, ICONMA prides itself on creating an employment

environment that supports and encourages the abilities of all persons regardless of race,

color, gender, age, sexual orientation, citizenship, or disability.


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Quality Engineer

Iconma, L.L.C.