Inginaire is looking for a Quality Engineer to support all phases of the Quality Management System for our client in Bloomington, MN. Our client is a fast-growing dynamic leader within the Twin Cities medical device industry. They offer technical services to assist medical device OEMs throughout the nation with clean room assembly and packaging operations. As an employee you will enjoy a culture founded on teamwork, respectful communication, creative problem solving, dependable follow through and excellent customer service. This position will be responsible for providing technical quality engineering support for customers, processes and systems, including driving continuous improvement activities.Duties
- Perform QA technical review and approval of documentation for products.
- Guide CAPA team to root cause and determine appropriate verification of effectiveness strategies. Mentor others in root cause analysis & problem-solving skills.
- Support product and process risk control measures and files (FMECA, pFMEA).
- Report Quality data for management reviews and other Quality reporting (CAPA, NCMR, Compliant, as well as others.).
- Four-year degree in technical field or equivalent combination of education & experience.
- 2-4 yearsâ€™ experience in regulated industry (FDA/ISO) preferred.
- Training in statistics & experience using Minitab Software preferred.
- Computer proficiency. Ability to read, analyze and interpret common technical procedures.
- Knowledge in working with Root Cause Analysis, using quality tools such as Fish Bone Diagramming, Flow Charting, 8D and Value Streaming.
- Knowledge or training pertaining to FDA and ISO regulations.