Description
Quality System Engineer (m/f)
Reference: -en
Start: asap
Duration: 12 MM
Main tasks:
- Assist the running of the CAPA system, create summaries, attend meetings and contribute to root cause analysis determination
- Perform internal audit, assist in audit scheduling and update all related actions
- Assist and lead the compilation and execution of validation protocols for new product/processes and software
- Ensure correct implementation as per standard validation procedures
- Re-validate engineering change, deviation analysis or upgrade in systems and materiel
- Responsible for the introduction and correct use of statistical QA methods into the production environment, and provide technical resource for production team on relevant IQ/OQ/PQ protocol issues
- Assist the maintenance of the Master Validation Plan and Critical System Changes for validated systems
- Review and identify potential improvements with the Leeds Quality System and products to better meet regulatory requirements
- Document and maintain in good order all relevant Quality assurance sections of Device Development History File and DMR as directed
- Co-ordinate product/technology transfer between facilities from a QA perspective, develop and utilize DFMEA/PFMEA and other QA risk analysis techniques in order to minimize potential risk during development/implementation activity
- Ensure compliance with all Documented Quality system, FDA QSR’s and ISO 9001 requirements during day to day and assigned audit/CAPA activities
Main qualifications
- Experience and awareness of quality systems and techniques such as ISO9001 and SPC
- Engineering background in manufacturing, with a proven ability to interpret and create engineering specifications and procedures
- PC literate, and familiar with MS Office applications
- Good understanding of engineering drawings and geometric Tolerating
- Good communication and presentation skills in order to effectively communicate technical and QA requirements to all functional departments and external facilities
- Determined approach to problem solving, and ability to make appropriate decisions concerning product/process disposition and general Quality assurance procedural suitability
- Ability to deal with flexible workload and type is essential, and also an ability to work productively within a project
- Self-motivated and self-disciplined, must be able to work unsupervised
Main advantages:
- A very renowned company
About us:
Our many years of recruitment experience and specialist knowledge of the engineering job market make us a strong partner for engineers and technicians. We maintain intensive relationships with customers across all industries and so can provide engineering specialists with exciting projects and attractive job opportunities. Whether it's working with an international automotive manufacturer or a regional market leader in mechanical engineering, drawing on your interests and experience, we will find the right job to suit you. Because with us, specialists find their ideal working environment – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.
My contact at Hays:
My contact person:
Silvia Charro Lopez
Referencenumber:
Make contact:
Email: