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Quality & Regulatory Officer - Medical industry

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.

Page Personnel | Vilvoorde - Zaventem | Permanent, Full-time

Published on Jobat.be 31 days ago

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

Quality & Regulatory Officer - Medical industry

Job 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

Offer

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

Interested?

Page Personnel Belgium
Pauline Swolfs
+32 2 509 45 42
Bastion Tower Marsveldplein 5 Place du Champ de Mars 5 1050 Brussels
Vilvoorde - Zaventem

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Characteristics

Requirements

  • Academic Bachelor
  • Dutch, English, French

Offer

  • Permanent
  • Full-time

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