Auditor BE/NL - Antwerpen

Vacancy information

Publication date:February 23 2021
Employment type: Permanent
Sector: Medical Devices
Function Group: Quality/RA

Function Group: Quality/RA / QA Auditor

Organization

For a large, internationally operating organisation active in the diagnostics industry, we are looking for an Auditor. This organisation’s mission is to improve the health of people around the world. They have developed multiple systems to improve several types of processes in the healthcare industry.

Function

In this role, you will be overall responsible to conduct quality-related internal audits to assure that national and international regulations, standards and procedures are met. You will work closely with the auditees to collect relevant information. You will provide update reports to management regarding the audits. Additionally, you will evaluate the evidence in the Audit Action Plan (AAP) and, with management, develop new plans to address inadequate AAP documentation when required. Lastly, you will maintain all data in the software database.

Requirements

For this role, we are looking for someone who has:

  • Bachelor in a science field such as Biology, Chemistry, Engineering or other related field
  • Around five years of quality experience and three years of auditing experience, gained in a Medical Devices or Pharmaceutical company
  • One of the following certifications: Certified Quality Auditor/ISO Lead Auditor Certified, Certified Quality Engineer, or Certified Quality Manager
  • Strong knowledge and experience with relevant regulation, such as: FDA QSR, ISO 13485, EU MDR/IVDR, and ISO 14971
  • Experience with quality tools such as: CAPA, Root Cause Analysis, Validation, etc.
  • Fluency in English, both written and spoken
  • Very strong analytical skills
  • Very strong communication skills, including communicating with several types of stakeholders and levels in the organisation
  • The ability and willing to travel nationally/internationally on a regular basis

Offer

This role offers:

  • Competitive salary
  • Excellent employment conditions
  • Multiple possibilities for further development of your career, nationally and internationally
  • Training and education

Application

If you are interested in this job, or in similar ones, please feel free to contact me directly.

Saskia Cepella
Senior Associate Quality & Clinical | Medical Devices

+31(0)6-13143973
+31(0)23-7548660
s.cepella@qtcrecruitment.com

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