Quality Systems Engineer: Auditor & Training Lead

Werfen Immunoassay; Lliçà d'Amunt; On-site; EUR 52,000 - 68,000; Full time

Job summary

Werfen is seeking a QS Engineer to maintain the core Quality Management System (QMS) processes, including document control, change control, internal audits and training management. The role requires autonomy in planning, coordinating and executing audits, and serving as a SME for QS processes across the organization.

The position involves continual improvement of the QRA function, CAPA management, and participation in cross-functional quality initiatives with exposure to regulatory registrations.

Qualifications

• Bachelor’s degree in Chemistry, Biotechnology or other Sciences with relevant health-related experience.
• Master’s degree in Quality Management is a plus.
• Minimum 3 years in a similar position.

Responsibilities

• Organize and coordinate internal and external audits, including planning, execution and follow-up.
• Lead audit activities and host frontroom/backroom during audits.
• Develop the annual Quality Training Program and monitor its execution.
• Maintain the Documentation Management System and oversee change control activities.
• Respond to customer quality questionnaires and manage CAPA processes.

Skills

Microsoft Office

Adobe

English

Spanish/Catalan

Education

Bachelor’s degree in Chemistry/Biotechnology/Sciences

Master’s degree in Quality Management

Tools

SAP

Job description

Werfen is seeking a QS Engineer to maintain the core Quality Management System (QMS) processes, including document control, change control, internal audits and training management. The role requires autonomy in planning, coordinating and executing audits, and serving as a SME for QS processes across the organization.

The position involves continual improvement of the QRA function, CAPA management, and participation in cross-functional quality initiatives with exposure to regulatory registrations.