Job Information
AGILITI Quality Engineer II in MILWAUKEE, Wisconsin
JOB REQUIREMENTS: Job Description: POSITION SUMMARY: 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. This position will be primarily focused on new product development and supplier qualification. 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, execution, and maintenance of equipment validation activities. (IQ, OP and PQ) Coordinate planning, execution and maintenance of tooling verification and validations in conjunction with manufacturing and engineering teams. Participates in and may lead plant Material Review Boards (MRB) to assist with investigations and disposition of product nonconformances. Develops and maintains process control plans for laser cutting equipment and robotic welders collaboratively with manufacturing and engineering teams. Coordinates collaboration with manufacturing to develop in-process inspection plans. 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 an ISO regulated manufacturing environment. ISO13485 experience preferred, but not required. Working knowledge and experience in metrology lab preferred, but not required. Working knowledge of ISO14971 Risk Management preferred, but not required. Working knowledge of IEC 60601-1 Safety standards preferred, but not required. Advanced Product Quality Planning experience (APQP) 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,... 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/F74AF215FA4D4088