Qualification/Validation Engineer in Le Locle
Jocelyn Blackham is recruiting for a Quality Engineer/Validation Engineer to join a company in the Medical Device industry at their site based in Solothorn on a contract basis till the end of July 2019, with the possibility of extention.
This role is based at our client's site in Le Locle. The 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.
The main purpose of the role will be to:
- 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.
- 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. Escalation of quality issues as appropriate.
Further responsibilities will include:
- Demonstrates strong computer skills, such as the use of Microsoft Office, Minitab, and databases.
- Strong knowledge and skills in PLM system, Agile PLM, SAP, Windchill, Adaptive will enhance candidacy.
- Must be highly organized, creative, articulate and analytical.
- Demonstrates strong written, verbal and presentation skills.
- Ability to multi-task independently with minimal supervision.
- Supporting Base Business and Production Improvement Initiatives.
- Ensuring 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.
- Assisting in the development of manufacturing and inspection procedures.
Your Background:
- Previous 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.
EDUCATIONAL REQUIREMENTS:
- 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.
Please note this role requires fluent spoken and written English Skills. French spoken and written skills would be an advantage.
For more information or to apply for this position, please contact Jocelyn on 0417276793 or email jblackham@ckqls.ch. Please quote reference QLS43896 in all correspondence.