Sr. Quality Engineer for Electro:Mechanical device PY - (Minneapolis, MN)

Position summary Provide Quality Engineering support to product development and inspection teams for Electro:Mechanical device. Provide support for Final Design Freeze and Product Release. Support the incoming inspection department and in:process inspections where required. Review component requirements and validations to support key development and continuous engineering projects. Approve key deliverables in support of product launch, which include: component requirements, design and product risk assessments, shelf life validations, and sterilization validations and more. Work with R and D engineers and Inspectors to prepare material specifications, and inspection documentation for new products. Set inspection requirements, set inspection methods and inspection sampling plans. Assist with non:conforming materials, including supplier contact and maintenance. Self:motivated worker. Ability in HPALM, preferred. Must have working background of GMP and ISO 13485 requirements.