Quality Inspector Technician

Quality Assurance St. Paul, Minnesota


Description

Putting a new spin on your career

Working at CSI means being a part of something greater than ourselves. We think big and move fast. From creating revolutionary technologies, to working with world class physicians and teams, we don’t simply work, we save lives. We have big company drive and small company vibe where your daily impact can be felt company-wide. If you are curious, ambitious and dedicated, you will love our community. Grow with us!



Summary
:

The Quality Inspector Technician will assist with coordination of the daily receiving inspection workflow, while ensuring all documentation is complete and accurate, including all training files.  The position requires a highly motivated, positive individual that can work both independently and in a “team” environment.  The Quality Inspector Technician will provide support to all Receiving Inspection employees, and communicate all trends and problems to the Quality Inspection Supervisor.  This individual must be dedicated to the success of CSI and its quest to continually improve its operations, as well as perform duties to manufacture CSI products, meeting FDA, OSHA, GMP/MDD and ISO compliance requirements.

Qualifications:

  • High School diploma / GED required
  • Previous medical device experience preferred.
  • Microsoft Office computer skills
  • Good written and oral communication skills
  • Ability to understand written processes
  • Ability to use inspection tools and equipment (Calipers, Micro-Vu, Rulers, Pin Gages Micrometer, Laser Micrometer)
  • Ability to read and apply technical data from prints
  • Ability to communicate effectively with a variety of people and customers
  • Previous experience with CMM or other automated inspection equipment.

Responsibilities:

  • Perform inspections for incoming raw materials using AQL Sampling Plan and First Article Inspection
  • Initiate and complete material actions for suspect and/or scrap material
  • Complete Nonconformance procedure and paperwork
  • Assist engineers with part qualifications
  • Complete and file all quality documents
  • Perform manufacturing medical finished device inspection
  • Authorize product release for shipment in accordance with CSI requirements
  • Complete required forms, documents, and other items as may be needed to release product for shipment
  • Finalize device history records
  • Initiate and complete material actions (example: failures, nonconformance, stop, hold, etc.) based on finished device sterilization results
  • Quality check quality records
  • Fill out paperwork legibly and accurately
  • May perform other duties as determined or assigned by management

Specifications/Other:

  • Must be able to lift up to 50 pounds.
  • Must be able to work in a sitting or standing position and be able to twist or turn the body continuously throughout the day.
  • Job requires repetitive movement of both hands continuously
  • Work is performed on-site in a manufacturing environment

CSI is an EEO/AA company: Women, Minorities, the Disabled and Veterans are encouraged to apply. If you are a job seeker with a disability and require accessibility assistance or reasonable accommodation to apply for an open position, please contact the Recruiting Department at Cardiovascular Systems, Inc., 1225 Old Hwy 8, New Brighton MN 55112, or call (651) 259-1600.