Spectralytics
  • 30-Nov-2018 to 15-Jan-2019 (EST)
  • Spectralytics
  • Dassel, MN, USA
  • 15.00 - 25.00
  • Full Time

Spectralytics, a Cretex Medical company, is a laser micromachining and assembly company that focuses on implantable devices and components to medical device manufacturers. Join our dedicated team of professionals!

Position summary

The Quality Auditor performs basic dimensional and visual inspections for various manufacturing processes. Performs inspections using various methods and equipment, completes appropriate documentation to ensure operations within company and GMP guidelines, policies and procedures.

 

Essential Job Functions                                                      

    • Inspects received materials, tight tolerance components, instruments and assemblies relating to quality, appearance and performance
    • Interprets and accurately documents the results of the inspections and testing
    • Reports and isolates/segregates non-conforming product
    • Uses a variety of inspection measurement tools/gages (micrometer, caliper, gage pins, indicators, thread gages, profilometer, optical comparator, microscopes)
    • Operates various precision testing equipment including, but not limited to Tool Scope, OGP, MicroVu and Keyence
    • Reads and complies with work instructions, set up sheets, and checklists
    • Enters production information into the ERP system on a timely basis
    • Accurately records and reports hours worked
    • Maintains an organized work area (5S) to include workstations, equipment, walkways, and locker rooms
    • Participates in the Operational Excellence Program
  • Understands and complies with the Cretex professional competencies, company policies, and employee manual
  • Adheres to all safety policies; includes wearing personal protective equipment when required
  • Supports and complies with the company's Quality System, ISO, and medical device requirements
  • Completes all other work duties as assigned   

 

Minimum Requirements, Education & Experience (incl. KSA's and certifications)

  • High school diploma or equivalent (GED)
  • Experience with multiple types of measuring equipment
  • Experience working in a manufacturing setting
  • Experience working independently and under pressure with multiple deadlines
  • Experience working with Enterprise Resource Planning Systems (ERPs)
  • Ability to maintain organized work environment
  • Basic Blueprint Reading skills
  • Basic knowledge of Geometric Dimensioning and Tolerance (GD&T)
  • Ability to work from customer supplied drawings and specifications
  • Competent with Microsoft Office
  • Ability to read, comprehend, follow and document work instructions, standard operating procedures, and training documents
  • Mechanical Aptitude
  • Dexterity and hand and eye coordination
  • Attention to detail
  • Strong problem solving skills
  • Ability to prioritize work and manage multiple tasks
  • Ability to take direction from the area manager
  • Ability to collaborate and assist team members, demonstrating diplomacy and tact when interacting with other departments/peers
  • Ability to cross train in other areas of production when required
  • Ability to work in a manufacturing environment

Desirable Criteria & Qualifications

  • Quality training and/or certifications
  • Knowledge of ISO 9001/13485
  • Experience working in a Quality function
  • Experience handling non-conforming product/non-conformance reports
  • Experience/knowledge of Lean Manufacturing processes
  • High degree of Metrology skill
  • High degree of blueprint reading skill
  • Understanding and experience with Microsoft Excel

 Applicants will receive consideration for employment regardless of their race, color, creed, religion, national origin, sex, sexual orientation, disability, age, veteran status, marital status, family status, status with regard to public assistance, or any other protected status as required by law.

Spectralytics
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