Quality Engineer in Oberdorf
Quality Engineer - Oberdorf, Switzerland
Alex Tosney is recruiting for a Quality Engineer to join a global medical device company at their site based in Oberdorf on a contract basis until the end of the year.
Role Details: The primary purpose of this position is to support manufacturing operations in all areas to prepare for the MDR changes coming in 2020.
Further responsibilities will include to:
- 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 noncompliance 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.
- Assists in the development of manufacturing and inspection procedures.
- Support the Manufacturing Organization in creation, review and release of MPI & Risk Management Activities.
- Be 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. In order to be considered for this role, you will be required to have the following qualifications, skills and experience:
- 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 4 years of experience preferred.
- Experience with packaging, Laser, and CNC processes and equipment, preferred.
- GERMAN IS REQUIREMENT FOR THIS POSITION.
This is an excellent opportunity to join a world leader in the medical device field.
For more information or to apply for this position, please contact Alex Tosney on 0041 (0) 417276793 or email atosney@ckqls.ch. Please quote reference 44818 in all correspondence.
