Quality Systems Engineer (Llissá de Munt)

Quality Systems Engineer (Llissá de Munt)

02 oct
|
Werfen Immunoassay
|
Llissá de Munt

02 oct

Werfen Immunoassay

Llissá de Munt

The Quality Systems (QS) Engineer is responsible for maintaining the core Quality Management
System (QMS) processes, including Document Control, Change Control, Internal Audit and
Training Management, and ensure the company is compliant with all applicable regulations and
standards. The QS Engineer operates with a high degree of autonomy in the planning,
coordination and exectuion of audits, and, upon qualification through the internal auditor
qualification program, is authorized to conduct internal audits independently. The role serves
also as a subject matter experts (SME) for the QS processes, providing technical guidance and
support across the organization. In addition, the QS Engineer actively contributes to the
continual improvement of the QRA function and supports the effective management of Non-
conformance, Corrective and Preventive Actions (CAPA), and other quality system improvement
initiatives.

Job Summary
The Quality Systems (QS) Engineer is responsible for maintaining the core Quality Management
System (QMS) processes, including Document Control, Change Control,



Internal Audit and
Training Management, and ensure the company is compliant with all applicable regulations and
standards. The QS Engineer operates with a high degree of autonomy in the planning,
coordination and exectuion of audits, and, upon qualification through the internal auditor
qualification program, is authorized to conduct internal audits independently. The role serves
also as a subject matter experts (SME) for the QS processes, providing technical guidance and
support across the organization. In addition, the QS Engineer actively contributes to the
continual improvement of the QRA function and supports the effective management of Non-
conformance, Corrective and Preventive Actions (CAPA), and other quality system improvement
initiatives.

Key Accountabilities

• Organize and coordinate internal and external audits, including planning, execution and follow-up activities.
• Conduct in

📌 Quality Systems Engineer (Llissá de Munt)
🏢 Werfen Immunoassay
📍 Llissá de Munt

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