Quality System Engineer (Llissá de Munt)

Quality System Engineer (Llissá de Munt)

02 oct
|
Werfen Immunoassay
|
Llissá de Munt

02 oct

Werfen Immunoassay

Llissá de Munt

Werfen is a growing, family-owned, innovative company founded in 1966 in Barcelona, Spain.
We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. We operate directly in 30 countries, and in more than 100 territories through distributors.
Our Headquarters are in Barcelona, Spain and our Technology Centers are located in the United States and Europe. Worldwide sales exceeded €2.2 billion in 2024, and our workforce is more than 7,000 strong.

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 ensuring 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 execution of audits, and, upon qualification through the internal auditor qualification program, is authorized to conduct internal audits independently.




The role also serves as a subject matter expert (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 internal audits upon successful completion of the Internal Auditor Qualification Program.
• Lead backroom activities during external audits and host the frontroom activities during internal audits.
• Develop the annual Quality Training Program based on identified organization needs, support its deployment, and monitor its effective execution.
• Collect, analyse and communicate training

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

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