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