Quality & Regulatory Officer - Medical industry

4 jours restants

Région
Flemish Brabant, Diegem
Salaire
Negotiable
Publication
mardi 26 février 2019
Date limite
mardi 26 mars 2019
Réf
566159/001
Contact
Pauline Swolfs
Niveau d'expérience
2 à 5 ans d'expérience
Type de contrat
CDI
Temps de travail
Temps plein

The purpose of the quality and regulatory officer is to implement and maintain the quality management system following the requirements described in the IS09001 & ISO 13485 standards.

Client Details

Our client is a multinational group active in pharmacy, diagnostic and biomedic divisions.

Description

As Quality Officer, these are your responsibilities:

  • Assure that the company guidelines or company official documents are up to date, available and distributed toall employees
  • Assist all employees on the quality management system, company processes and QMS procedures and to promote the awareness of customer requirements throughout the organization.
  • Coordinate and communicate all product complaints to the suppliers.
  • Report to management on the performance ofthe quality management system, advice management on quality related improvements/changes.
  • Reports of KPI's, analysis of complaint statistics, credit note statistics, returned
    product statistics etc... with the goal to define the need for improvement/ improve the
    internal company processes.
  • Perform internal department audits and follow up corrective and preventive actions
  • initiate actions to prevent the occurrence of any non-conformity related product and service, coordinating, recommending or providing solutions on quality improvement through designated channels
  • To update and maintain the risk management file: establishing risk
    acceptability criteria, risk analysis, risk evaluation, risk control and monitoring.
  • To assure follow up of supplier shortcomings and field safety
    activities (withhold, field safety notice, recall ... ), report vigilance activities and if
    applicable contact competent authorities.
  • To destroy stock (Expired, damaged, quarantine, instruments,
    biohazard waste...) in cooperation with F&A department according local legislation.
  • Supervising delivery or installation of non-conforming products.
    Supervising the quarantine area. Supervising customer returned products
    (Visa/approval of outgoing products) and manage return of non-conforming products
    to suppliers.

Profile

For the role of Quality Officer, we are looking for someone with following profile:

  • Fluent in Dutch & English, knowledge of French.
  • Min. Bachelor diploma or equivalent experience in Quality
  • Knowledge of ISO standards
  • Analytical and excellent communication skills
  • Willing to propose improvements and procesoptimizations
  • Eager to learn

Job Offer

Our client offers an attractive salary package within a dynamic team and interesting industry.