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.

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.