Tech Manager Medical Devices
SIRE
Antwerpen, Belgium
5 dagen geleden

The company

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.

Role description

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.

Responsibilities

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
  • Requirements

  • 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
  • Other information

    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.

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