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Quality Engineers/Validation Consultant

Eingestellt von Experis AG

Gesuchte Skills: Engineering, Plm, Consultant, Engineer

Projektbeschreibung

QUALITY ENGINEER/VALIDATION CONSULTANT

Experis IT is Europe's leading IT recruitment agency. With offices in Zurich, Basel, Geneva and Lausanne, we specialise in the Information Technology sector.

On behalf of our client, one of the leading Medical Devices companies in Switzerland, I am looking for a Manufacturing Engineer. This is a contract position for 8 months located in Le Locle.

If you are interested in this position, then please check the criteria below:

JOB SUMMARY

This role supports manufacturing operations in the areas of process development, tool design, machine programming & layout, machinery & equipment, continuous improvement and other duties associated with engineering support of production.

YOUR TASKS & RESPONSIBILITIES

- Support process validation strategy and writes and executes 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
- Assist in the development of manufacturing and inspection procedures
- 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. Escalation of quality issues as appropriate
- Support Base Business and Production Improvement Initiatives

EXPERIENCE YOU MUST HAVE

- 4-6 years of experience in quality engineering is required
- Experience with ISO 9000, ISO 13485 and GMP
- Experience in Design and Process validation
- Quality Tools Knowledge
- Bachelor of Science Degree from accredited institution in Manufacturing Engineering, Mechanical Engineering, Industrial Engineering, or a related degree
- Demonstrates leadership qualities including confidence, transparency, integrity, innovation, passion, patience and tenacity
- Demonstrates strong computer skills, such as the use of Microsoft Office, Minitab, and databases

NICE TO HAVE

- Previous experience working in a regulated industry, such as Medical Devices
- Six Sigma or Lean Sigma certification or 4 years of experience
- Experience with packaging, Laser, and CNC processes and equipment
- Strong knowledge and skills in PLM system, Agile PLM, SAP, Windchill, Adaptive

OVERVIEW

- Start date: 19.11.2018
- End date: 31.07.19
- Work location: Le Locle
- Workload: 100%

Interested in this opportunity? Kindly send us your CV today through the link in the advert. However, should you have any questions please contact Alexander Russell or via email

Projektdetails

  • Einsatzort:

    Le Locle, Schweiz

  • Projektbeginn:

    asap

  • Projektdauer:

    8 months

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Experis AG