Job Information
AGILITI Quality Engineer II in MILWAUKEE, Wisconsin
JOB REQUIREMENTS: Job Description: The Quality Engineer II will utilize and maintain quality engineering systems and practices in collaboration with Agiliti manufacturing and design centers that meet and exceed internal, customer, and regulatory requirements. PRIMARY DUTIES AND RESPONSIBILITIES Acts as a team member in supporting quality decisions and practices. Applies systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues. Applies statistical methodologies for assessment and to resolve potential product and quality system issues. Develops and maintains testing plans, models and methods for raw materials, materials in process, and finished goods. Collaborates with Design, Manufacturing, and Supply Chain teams to select and monitor suppliers. Coordinates planning and execution of first article inspections and approvals. Coordinate planning, execution and maintenance of tooling verification and validations in conjunction with manufacturing and engineering teams. Leads activities to support medical device manufacturing, such as Risk Management, Process FMEA, and Quality Control Plans. Plans, develops, and oversees execution of verification and validation protocols. Leads advanced product quality planning activities and assists in preparing new product designs for certification testing. Participates in projects and cross functional teams. May lead mid-scale projects. EXPERIENCE Bachelor\'s Degree (BS) in Engineering, Scientific, or Technical related subject required. 3-7 yrs. of relevant experience, preferably in Design and Development in an ISO13485 regulated environment. ISO13485 and FDA 21CFR820 highly desired. Working knowledge and experience with metrology labs preferred and GD&T. Experience with medical device ISO14971 Risk Management. Working knowledge of IEC 60601-1 Safety standards preferred, but not required. Use of statistical analysis software for SPC & CPk Analysis Tooling and fixturing development and qualification (FAI and Gage R&R) SKILLS & ABILITIES Proficient computer skills in MS Office Suite, including MS Project and Visio. Working knowledge of CAD software preferred (i.e., SolidWorks, Autodesk, etc.) Strong analytical skills and attention to detail Strong technical writing skills and effective communication skills Strong presentation, facilitation, and project management skills DISCLAIMER This job description in no way states or implies that these are the only duties to be performed by the employee in this position. It is not intended to give all details or a step-by-step account of the way each procedure or task is performed. The incumbent is expected to perform other duties necessary for the effective operation of the department and the... For full info follow application link. We are proud to be an EEO/AA Employer/Vet/Disabled. We maintain a drug-free workplace and perform pre-employment background and drug testing. ***** APPLICATION INSTRUCTIONS: Apply Online: ipc.us/t/F6E32338E97445E7