Senior Quality Technician

Job Description

Job Description

A medical device client is looking to hire a full time, Senior Quality Technician onsite in Eden Prairie, Minnesota. This Monday-Friday, onsite quality professional will need to perform material and product assessment testing in support of medical device development and manufacturing in compliance with GMP. This person will be assigned complaint, RMA tasks and perform engineering related requests as assigned. The individual is also responsible for, receiving and in-process inspections, material release in support of medical device manufacturing. Our client is looking for someone who will be responsible for reviewing and approving DHRs prior to product release and should feel comfortable supporting the administration of quality systems within the electronic quality management system. This position works cross functionally with process stakeholders to ensure quality system processes are documented appropriately and are completed within the expected timeframes.

Must Haves:

• HS diploma and minimum 2 years relevant medical device/ISO 13485 experience or 2 yr degree.
• Knowledge and experience with electronics manufacturing preferred.
• Knowledge of quality systems including use of electronic quality management systems software preferred.
• Knowledge of electrical and mechanical testing techniques.
• Good math and technical skills.
• Excellent computer skills including MS Office.
• Maintains positive attitude when working with peers, customers or suppliers.
• Comfortable working in a self-directed team environment and giving or asking for instructions.
• Demonstrate an understanding of the medical industry.
• Provide training to peers on technician level skills.
• Works effectively on cross functional teams to establish appropriate processes pertaining to quality
• Ability to review, analyze, summarize and interpret data; draw conclusions and make appropriate recommendations and decisions.

What You’ll Do:

• Conduct functional testing as required by component drawings, manufacturing instructions, and/or test instructions.
• Responsible for receiving inspection activities including, but not limited to inspection and gathering all defined requirements and documentation to release parts/components.
• Responsible for performing in-process and final component, sub-assembly and product inspection.
• Document non-conformance reports once parts fail specification or requirements.
• Performs and/or supports troubleshooting, investigations and problem solving of issues and non-conformances.
• Complaint related tasks.
• RMA tasks.
• Assures quality systems documentation and record keeping activities are carried out and completed in compliance with established procedures and work instructions.
• Demonstrates safe work habits, maintains clean and safe work area.
  Completes all other duties as assigned by supervisor.
• Develop and write quality systems procedures as requested by supervisor.
  Provides support during customer audits.
• Supports supervisor in preparation of Management Review.

Pay of $32 – 36 an hour, direct hire, full time + benefits