Quality Systems Engineer: Audits, Training & Compliance

Winid; Lliçà d'Amunt; Presencial; EUR 42.000 - 64.000; Jornada completa

Descripción de la vacante

Werfen seeks a QS Engineer to maintain the core QMS, manage audits, and drive continual improvement across the organization. You will act as an SME for QS processes and support CAPA and change control activities.

The role requires a bachelor’s in a science field, several years in quality, and fluency in English with Spanish or Catalan skills. SAP knowledge and regulatory awareness are valued in this on-site Barcelona area position.

Formación

• Bachelor in Chemistry/Biotechnology or related sciences required.
• Minimum 3 years in a similar quality role is expected.
• Knowledge of regulatory requirements for medical devices/IVD is essential.
• Regulatory/regulatory affairs experience is a plus.

Responsabilidades

• Organize and coordinate internal and external audits with planning and follow-up.
• Lead audit activities and support CAPA and change controls.
• Develop and deliver the Quality Training Program and materials.
• Maintain the Documentation Management System and Change Management.
• Monitor KPIs and drive continual quality improvements.

Conocimientos

MS Office

Adobe applications

SAP (basic)

Quality management

English (advanced)

Spanish/Catalan

Educación

Bachelor’s degree in Chemistry, Biotechnology or Sciences

Master’s in Quality Management (advantage)

Herramientas

SAP

Descripción del empleo

Werfen seeks a QS Engineer to maintain the core QMS, manage audits, and drive continual improvement across the organization. You will act as an SME for QS processes and support CAPA and change control activities.

The role requires a bachelor’s in a science field, several years in quality, and fluency in English with Spanish or Catalan skills. SAP knowledge and regulatory awareness are valued in this on-site Barcelona area position.