Our client is a professional Medical Devices organisation, based in Antwerpen Belgium. This company is an international organisation that provides certifications for Life Sciences companies.
As quality and regulations become more strict and complex, they are looking for some new employees.
In your position as technical manager, you will gain the responsibility to ensure the quality of the company’s auditors.
On a daily basis, you will provide support to the auditors in the field. Furthermore, you will keep track of the developments within the Medical device market concerning quality and regulatory activities.
You are the key person when it comes to guidance, coordination and insurance of technical qualifications for the auditors.
On a daily basis, you will support the auditors with their projects. Furthermore, your responsibilities contain :
Assess and improve technical qualifications of the staff members
Achievement of company targets
Scheduling and execute QMS audits for the medical devices sector according the company’s procedures
Assessment of audit results and certification matters
Create cohesion and collaboration within the organization
Point of contact whenever there are issues with clients, notified bodies and other authorities
Extensive experience with medical devices varying from class I to III
Excellent knowledge of ISO 13485
Great knowledge of relevant regulations from the European and international markets (such as FDA and CE- marking)
Preferably experience as (Lead) auditor
Excellent analytical and problem-solving skills
Fluency in English, Dutch and business level French
Strong in communication skills
Excellent organizational and managerial skills
Evidence of experience in relationship building and maintenance of relations with authorities and other external stakeholders
Bachelor or Master in Life Sciences
Minimal 5 years of experience in the Medical Devices industry in both manufacturing and distribution environments
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Juliette van Kraaij.