Zimmer Biomet BVBA , located in Wemmel, is looking for an QARA Specialist
Zimmer Biomet is one of the leading international companies in the field of medical technology. Together with more than 18,000 people worldwide we deliver medical implants to more than 100 countries.
Our innovations help treat disorders of, or injuries to, the bones, joints, and supporting soft tissues. Together with healthcare professionals, we help millions of people to live better lives.
It is our promise to look beyond what is possible and discover what is possible next and to help healthcare professionals and their patients progress to the next level.
Therefor our mission is to alleviate pain and improve the quality of life for people around the world.
The purpose of this job is to maintain the Quality Management System to fulfil the ISO 13485 requirements and Zimmer Biomet requirements.
You will work in close collaboration with local management in Belgium, QA / RA Netherlands and the QA / RA manager central region.
Principal Duties and Responsibilities
Actively support Product Market Surveillance
Manage & rool-out Field Safety Corrective Actions (FSCA), in collaboration with Operations, Customer Service, Product Management & Sales
Report Product Complaints to the Legal Manufacturers, as appropriate
Manage questions from legal manufacturer and assure follow up
Coordinate product returns
Monitor the Quality Holds and Field Notifications
Coordinate the monitoring of Customer Complaints
Manage internal and external communication : with local colleagues, international contacts within the company and with customers
Maintain the Controlled Documents of the local QMS, support and write policies if needed
Coordinate and follow up Corrective and Preventive Actions Plans that result from any source to ensure a continuous improvement culture
Stop shipment to customer in case of potential risk related to the product quality or safety, or in case of infringement of applicable
Report to management any potential issue that could affect QMS, the product quality or the patient safety.
Expected Areas of Competence
Fluent in Dutch, French and English, both spoken and written
Discretion and confidentiality
Good reporting skills
Good knowledge of Microsoft Office tools; Data collection in excel
Good oral and written communication (customer and internally) with several personalities and functions
Education / Experience Requirements
Basic Knowledge of Quality Systems
Certificated education in quality management is preferred
Min 1 year verifiable experience in quality assurance. Must be familiar with standard business platforms.
Knowledge of Quality Management system requirements is preferred, ideally in medical device industry in Europe.
Knowledge of legal and regulatory requirements applicable to medical devices is appreciated
Knowledge of the ISO 13485 is preferred
Rough percentage of time for regional / global travel : 5%