Quality Development Engineer II

Title: Development Quality Engineer IILocation: St. Paul MN 55112 (Onsite)Duration: 6-month (possible extension or contract to hire)Pay Range: $33-35/hr (The rate may be negotiable based on experience, education, geographic location, and other factors.)Years of Experience: 2–5 yearsEducation: Bachelor's degree in an Engineering discipline or experience in another technical field.Must-Have Skills:Design Verification Plans/ReportsRisk Management PlansLabeling VerificationCybersecurity Risk AssessmentDesign History File (DHF)Ability to work independently and contribute to teamsResponsibilities:Participate in or lead teams supporting quality disciplines, decisions, and practices.Lead on-time completion of design control deliverables.Support on-time execution of Quality Plans for internal Product Development Process (PDP), OEM-based Clinical Product Development (CPDP), and design change projects.Be accountable for generating PDP design verification test plans and reports for product/system requirements.Lead or support Risk Management activities from product concept through commercialization, including generating risk management plans and reports, completing and maintaining hazard analyses, FMECA, and Cybersecurity risk assessments.Lead identification of essential outputs and generate Essential Output reports.Be accountable for completing labeling verification activities and labeling verification reports.Work with Design Engineering to complete customer, system, and product requirements.Work with Design Engineering to complete product verification and validation.Ensure Design History File (DHF) content completion, integrity, and regulatory and standards compliance.Collaborate and communicate to resolve gaps.Complete document change request reviews in a timely and objective manner.Identify and implement effective process control systems to support product development, qualification, and ongoing manufacturing to meet or exceed internal and external requirements.Assist in implementing assurance, process control, and CAPA systems designed to meet or exceed internal and external requirements.Assist in the development and execution of streamlined business systems that effectively identify and resolve quality issues.Apply sound, systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues.Support all company initiatives identified by management and support Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.Additional duties may be identified by functional management based on current project/business objectives.Equal Opportunity Employer/Veterans/DisabledBenefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, an EAP program, commuter benefits, and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs that are direct hires to a client. To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit https://www.akkodis.com/en/privacy-policy. The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:· The California Fair Chance Act· Los Angeles City Fair Chance Ordinance· Los Angeles County Fair Chance Ordinance for Employers· San Francisco Fair Chance Ordinance