Quality Tech

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Quality Tech

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    Quality Tech
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Quality Technician

Position Overview                                                                 

This position is responsible for support the Quality department, key operational activities, customers and suppliers as necessary.

Duties & Responsibilities

  • Incoming, in-process and final inspection activities where necessary.
  • Participate in validations (e.g. IQ, OQ, PQ)
  • Support/drive non-conformances including suppliers, internal and customer complaints.
  • Support the documentation control processes.
  • Creates, revises and reviews quality documentation.
  • Work order review, verification and release.
  • Support cleanroom monitoring.
  • Interface with other departments; e.g. manufacturing, warehouse, sales.
  • Read and understand engineering drawings.
  • Familiar with GMP & GDP.
  • Proficient with PC and Office applications.
  • Team player with good written and verbal communication skills.

Scope of Power

  1. Has a right to:
    1. Taking independent decision regarding releasing/certification or rejection of medical devices production batches or production batch based on established procedures, obtained testing results, BHR and own experience. 
    2. Taking independent decision regarding releasing/certification or rejection of raw materials and packaging materials for medical devices and manufacturing process.
    3. Taking independent decision regarding obtained testing results for medical devices.

The decisions in this matter are fully independent from the opinion of direct supervisor, the Board of Directors or other person who could influence its decision.

  1. Has the right to stop production of nonconforming medical devices.
  2. Access to full information and documentation related to the packaging of medical products and the manufacture of medical devices.
  3. Access to all areas connected with the process of the manufacturing of medical devices.

Education & Skills

  • Experience in quality, preferably within regulated manufacturing environment, ig ISO 13485/FDA QSR
  • College preferred but will accept HS Grad with more than 3 years’ experience.
  • Cleanroom and/or packaging experience helpful.
  • Previous involvement in root cause and problem-solving groups.
  • Proficient with PC and Office applications.

Work environment

  • Work is performed in a Class 8, temperature controlled Clean Room.
  • Dress requirement per Gowning Procedure/Good Manufacturing Practice (QAD03-05).
  • Walking / Standing consistently for 8 to 10 hour shifts.

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