Description
- As a modern company, our client manages to constantly develop further and break new ground
Quality Engineer / Validation Consultant (m/f)
Reference: -en
Start: asap
Duration: 8 MM++
Main tasks:
- Support process validation strategy and write and execute engineering studies and process validation protocols and summary reports (Installation Qualification, Operation Qualification, Performance Qualification, Computer Software Validation and Test Method Validation)
- Develop and implement control plans consistent with product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc.
- Develop and implement appropriate process monitoring and control methods consistent with the level of process/product risk
- Assess and interpret common versus special cause variation in manufacturing processing and determine adequacy of current process limits
- Ensure the development of a comprehensive risk management plan for the product and process
- Document, justify, review or analyze whether a proposed change to a process will not enhance the risk level in some way beyond capability of current controls or whether change will result in potential non-compliance to a required standard such as the QSRs
- Assess the need for risk mitigation techniques given product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc. Determine effectiveness of these techniques on previously implemented improvements
- Support the Manufacturing Organization in creation, review and release of MPI & Risk Management Activities
- Responsible to originate/oversee/assist in the creation & release of change orders (COs) through Agile PLM software
- Conduct investigation, bounding, documentation, review and approval of non-conformances, CAPAs and customer complaints
Main qualifications
- Bachelor of Science Degree from accredited institution in Manufacturing Engineering, Mechanical Engineering, Industrial Engineering, or a related degree
- Profound experience in quality engineering is required
- Experience with ISO 9000, ISO 13485 and GMP
- Experience in Design and Process Validation
- Quality Tools Knowledge
- Previous experience working in a regulated industry, such as Medical Device is preferred
- Six Sigma or Lean Sigma certification or profound experience preferred
- Experience with packaging, Laser, and CNC processes and equipment, preferred
- Demonstrates leadership qualities including confidence, transparency, integrity, innovation, passion, patience and tenacity
Main advantages:
- A very renowned company
- You will work in an international environment
- Flat hierarchies
About us:
With over 15 years of experience in the pharmaceutical industry, biotechnology and medical engineering, we know the key contacts at companies that are recruiting for challenging jobs with real potential. The current high demand for staff has opened up exciting opportunities for dedicated professionals looking to develop themselves professionally and to further their careers. As recruitment specialists with an international network of contacts, we can offer you decisive advantages – 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.
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