Job Description

Quality Assurance Supervisor

Belgium Medical Devices
Posted by Luc Decat on 11/06/2020

For a global market leader in the field where medical devices meet pharmaceuticals, we are looking for a Quality Assurance Supervisor, working in the production site in Belgium. She/he leads a release team, responsible for the coordination and planning of batch file review activities.

Mission

  • Manage and control finished product release activities (drugs and medical devices),
  • Be the plant contact person for Advanced Surgery Medical Devices,
  • Project management (continuous improvement).

Essential Duties and Responsibilities:

Release activities

  • To be responsible for the coordination and planning of batch file review activities of the release team (<10 persons).
  • Monitor and improve the performance of the Release department.
  • Assure establishing all regulatory aspects (documentation and procedure updates,…)

Advanced Surgery (product release by plant)

  • Coordinate labeling changes, implementation, obsoletion as well as BOM updates with CMOs.
  • Own specifications (creation, change/update and obsoletion) in the company’s documentation systems
  • Write tests validation protocols, coordinating and executing tasks and writing protocol reports.
  • Coordinate/support Supplier notification of change and supplier corrective action request.
  • Product complaints: support the local complaint coordinator with complaint investigation and deviation, as applicable for medical devices.
  • Assure escalation of any potential issues and field action and gather data to assist field action process (in area of responsibility).
  • Facilitate interactions between the company and CMO/3rd party suppliers (including services)
  • Support external and internal audits when Medical Devices are in scope.
  • Ensure appropriate linkage with Advanced Surgery stakeholders (e.g.; RA, PDO, QA, labeling team).
  • Support in assuring the conformity of the plant to the Medical Devices regulation and applicable ISO standards.
  • Responsible for KPI (Key Performance Indicators) to be submitted to the Region/Global for the processes in area of responsibility for medical devises.

Project management (continuous improvement)

  • Lead, participate to the realization or coordination of Release and Advanced Surgery projects.
  • Participate in quality training development and deliver quality training like GMP.
  • Participate in the EMS/6S implementation and continuous improvement.

Qualifications

  • Minimum Bachelor degree in science or equivalent acquired through relevant experience.
  • 3 to 5 years of experience with release in a production environment
  • At least a first experience in people management
  • Fluent in English and French
  • Reside in Belgium
  • Dedication to Quality
  • Excellent knowledge Quality Systems requirements
  • Strong Project Management skills
  • Knowledge of GMP (Eudralex Vol. 4) and Medical Devices directive, ISO13485
  • Pharmaceutical, drugs and Medical Devices environment, deep knowledge on Quality Systems and compliance. Experience on project management
  • Very well organized, analytical and critical mind
  • Good communication skills and experience in people management : interact efficiently with team members and all stakeholders, effective communication
  • Team spirit minded.
  • Dynamic and motivated
  • Stakeholder and results orientated
  • Ability to work in a changing environment
  • Good interpersonal skills

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