A cutting-edge medical parts manufacturer in the Twin Cities is looking to bring on a direct hire, onsite Quality Engineer. This person will ideally come from Swiss Machining or Thermoplastics and will oversee all quality activities related to transfer of development activities, and manufacturing readiness, as well as ongoing support of design and manufacturing changes independent work at the supplier site. We are looking for someone who ideally comes from a contract manufacturing background and has direct production floor experience. Experience executing GR&R and doing qualification work is key but you'll also spend plenty of time client facing so definitely the best of both worlds!
Responsibilities:
- Support R&D design and engineering activities throughout the product transfer process, including V&V. Reviews new design specifications and provides input from component quality and manufacturability perspective.
- Work with the contract manufacturing company this client is using on NCs, including root cause investigations, MRB, CAPA, ECO implementation and process performance.
- Support and ensure to Develop process documentation and complete PFMEAs and Quality Control Plans.
- Define operation specifications related to the acceptance of the product, together with R&D and engineering.
- Definition of inspection tools and equipment, test methods and Equipment validations
- Write, review, and implement quality procedures.
- Verify that the product complies with applicable standards.
Must Have Skills:
- Bachelor's degree in Engineering / life sciences/or equivalent
- Knowledge of medical devices standards and regulation (FDA 21 CFR part 820) or aerospace standards 9001
- 5+ years of quality engineer experience with a machining, swiss and milling, or precision manufacturing background.
- Knowledge of medical device development activities (NPD / NPI)
- People person with positive, “can do” attitude
- Ability to work independently
- Experience working in a Swiss and/or CNC machining shop or with Thermoplastics
Salary range of $90-$110K base salary + quarterly bonuses