Quality Systems Lead – Medical Devices

TERUMO BCT, INC; Vlaams-Brabant; Sur place; EUR 90 000 - 120 000; Plein temps

Résumé du poste

Terumo BCT, INC. seeks a Quality Manager in Leuven to own and improve the QMS, ensuring CAPA, Document Control, Change Control and Validation processes are effective and compliant.

You will lead a quality team, interface with regulatory authorities, drive continuous improvement, and uphold our policy on quality requirements across manufacturing and service activities. Travel may be required.

Qualifications

• Engineering degree or equivalent to perform essential functions.
• Minimum 5 years relevant experience.
• Minimum 2 years supervisory experience.
• Understanding of electromechanical systems or systems engineering.
• Preferred 5 years in Quality Assurance or Regulatory Affairs for medical devices.
• Preferred ISO 13485 training.

Responsabilités

• Ensure implementation and effectiveness of global QMS processes for CAPA, Document Control, Change Control and Validation at Leuven site.
• Assist in improving quality processes and awareness of associates.
• Release to market all finished products manufactured at Leuven and ensure incoming goods release.
• QMS ownership and responsibility, including audits, training and management reviews.
• Interface with regulatory authorities and participate in audits and inspections.

Connaissances

Regulatory knowledge

Quality Systems

Leadership

Communication

Process ownership

Formation

Engineering degree

ISO 13485 training

Outils

PC software

Description du poste

Terumo BCT, INC. seeks a Quality Manager in Leuven to own and improve the QMS, ensuring CAPA, Document Control, Change Control and Validation processes are effective and compliant.

You will lead a quality team, interface with regulatory authorities, drive continuous improvement, and uphold our policy on quality requirements across manufacturing and service activities. Travel may be required.