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  • Location

    Netherlands

  • Job title:

    Quality Assurance Specialist

  • Sector:

    Medical Devices

  • Job ref:

    43137

The Company 
Our partner is a producer of high-quality Medical Devices with multiple production locations in Europe and in North America and a worldwide distribution network, are looking for a new colleague.

Role Description 

  • Support and coordinate EDC processes and make sure they meet all regulatory compliance requiremnts and are in line with QA procedures;
  • Advice and provide direction to sustain and approve the Quality System standards for the facility and employee training programs to help ensure regulatory compliance;
  • Interact with sources of supply regarding product quality complaints.


Responsibilities

  • Participate as needed in regulatory audits to ensure compliance with FDA and ISO regulations;
  • 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 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.

 

Requirements

  • Knowledge of Lean & Six Sigma preferred;
  • Min. 2 years operating experience (knowledge of SAP/ERP system);
  • Degree/technical education;
  • Ability to process document change requests and all Document control requirements on Qumas and understanding of applicable ISO13485 requirements;
  • Excellent communication skills;
  • Detail oriented.

 

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