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  • Location

    Netherlands

  • Job title:

    Quality Assurance Specialist

  • Sector:

  • Job ref:

    42890

  • Startdate:

    2020-01-16

Quality Assurance Specialist 

Generic for the role:

  • Maintain appropriate operating procedures and policies within corporate guidelines.
  • Perform, coordinate and follow up on internal audits 
  • Administer and initiate training activities in LMS
  • Perform Country Specific audits and product inspection reviews per approved procedures
  • Train Associates
  • Assist Supervisors in maintaining department standards in QA.
  • Interact with sources of supply regarding product quality complaints and coordinate related RGA’s, IDO’s and rework activities
  • Facilitate and coordinate any CAPAs required for the RO facility
  • Participate as needed in regulatory audits to ensure compliance with FDA and ISO regulations.
  • Participate on project teams to represent quality systems as needed.
  • Facilitate and coordinate any Non-Conformance Concessions required for the RO facility
  • To perform other job related duties as determined and assigned by management

 

Essential Functions of the Role:

  • Excellent communication skills
  • Ability to interface with a computer for long periods of time
  • Frequent walking throughout the facility
  • Hands on attitude
  • Reporting
  • Detail oriented


Education Requirements:

  • Minimum of a HBO work and thinking level 

 

Specialized Skills/Technical Knowledge:

  • Degree/technical education
  • Knowledge of SAP/ERP system (min 2 years operating experience)
  • Ability to process document change requests and all Document control requirements on Qumas and understanding of applicable ISO 13485 requirements.
  • Auditor Training
  • Knowledge of Lean & Six Sigma preferred
  • Basic technical writing skills required
  • Proficient computer skills, incl. MS office suite

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