Quality Engineer - Medical Devices

Job ID: 614844

Our client, a leading Medical Device company, is seeking a Quality Engineer for their growing team. Please note that is an onsite position in Minneapolis - if you are from outside the area, please only apply if you are interested in relocating to Minneapolis. See below for other details!

Top 3 Skills/Items Needed:

1. Medical Device supply chain/operations quality experience and understanding of 21 CFR 820
2. Change control/Non conformance/CAPA processes
3. Supplier change control experience

Responsibilities:

• Develops modifies applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product.
• Collaborates with engineering and manufacturing functions to ensure quality standards are in place.
• Devises and implements methods and procedures for inspecting testing and evaluating the precision and accuracy of products and production equipment.
• Designs or specifies inspection and testing mechanisms and equipment conducts quality assurance tests and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications.
• Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements.
• May specialize in the areas of design incoming material production control product evaluation and reliability inventory control and/or research and development as they apply to product or process quality.
• Read drawings, BOMs, GD&T. Experience in mechanical assembly and components. Ability to work with vendors on dimensions and order components.
• Ability to qualify equipment in medical device mfg. assembly line. Experience in working in a med device company in a cleanroom environment.
• Effectively facilitate team meetings, create and deliver presentations, and drive meetings to action-oriented decisions
• Use statistical techniques to analyze data capable of developing/reviewing/approving test plans and reports experience in Medical devices manufacturing

Requirements:

• Bachelor's Degree in Engineering and 2 years of medical device experience