Quality Engineer II - Medical Device

Akkodis is seeking a Quality Engineer for a Contract job with a client in Maple Grove MN. Ideally looking for applicants with a solid background in the Medical Device Manufacturing industry.Pay Range: $40 - $45hour; The rate may be negotiable based on experience, education, geographic location, and other factors.Please find the attached JD Below JOB RESPONSIBILITIES INCLUDE:Apply sound, systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issuesAct as an effective team member in supporting quality disciplines, decisions, and practicesWork within a cross-functional team to identify and implement effective controls and support commercial design changes, specifically with regard to quality and risk managementSupport the verification, validation, and usability testing to meet or exceed internal and external requirementsPerform regulatory standard assessments and support regulatory submissions to notified bodiesDemonstrate good working knowledge and application of validation and statistical techniques in order to comply with associated regulatory requirements and internal standardsDevelop, update, and maintain Design History File and Design Input Output documentation (Product Specification, Component Specifications, and Prints)Update and maintain product risk management tools (e.g., Hazard Analysis, Fault Tree, FMEAs)Minimum qualifications:Bachelor's degree in biomedical, Mechanical, or Electrical Engineering, or related field of studyPlus 2+ years of experience in design assurance, new product development, or related experience in a highly regulated industryDemonstrated use of Quality toolsmethodologiesStrong verbal and written communication skillsSelf-motivated with a passion for solving problems and a bias for actionEffectively work and collaborate in a hybrid (onsite plus remote) environmentPreferred qualifications:Prior medical device industry experience, particularly with medical electrical equipmentWorking knowledge of US and International regulations including ISO 13485, ISO 14971, IEC 60601-1, EN 62366, and Quality System RegulationsExperience in managing multiple projects across multiple organizational disciplinesEqual Opportunity EmployerVeteransDisabledBenefit offerings include medical, dental, vision, term life insurance, short-term disability insurance, additional voluntary benefits, commuter benefits, and a 401K plan. Our program provides employees the flexibility to choose the type of coverage that meets their individual needs. Available paid leave may include Paid Sick Leave, where required by law; any other paid leave required by Federal, State, or local law; and Holiday pays upon meeting eligibility criteria.To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit

Created: 2025-02-21