Overview 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.
Responsibilities 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 feedback to trainers to support the continous improvement of training content and delivery method.
- Oversee the preparation, implementation and completion of Annual Training Plans.
- Design and develop training materials, and provide guidance and support to other departments in training-related activities.
- Deliver Quality and GMP-related training sessions across the organization.
- Maintain the Documentation Management System.
- Manage documents of external origin.
Participate in the impact assessments
📌 Quality Systems Engineer (España)
🏢 Werfen
📍 España