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.
Our client is a multinational group active in pharmacy, diagnostic and biomedic divisions.
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
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
Our client offers an attractive salary package within a dynamic team and interesting industry.