quality engineer- validation consultant à Zuchwil

publié
contact
Olivier Worch, Bâle Professionals Health Care & Life Sciences
type d'emploi
temporary
postuler >

job details

publié
lieu
zuchwil, soleure
secteur
Life Sciences
type d'emploi
temporary
référence
11792
contact
olivier worch, bâle professionals health care & life sciences
téléphone
058 201 55 50
postuler >

description du poste

Randstad Professionals is currently looking for a Quality and Validation consultant who will be assigned an interesting challenge for a major client based in Solothurn . 

This contract is an unique opportunity to join a major client, global group focusing on the Healthcare sector  (Medical device, Pharma/vaccines, Consumer health).

The initial assignment will start immediately and will last until June 2019.

Project scope:   Implementation of EU MDR 2017/745 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. 

The successful candidate will be in charge of :  • Supporting process validation strategy and executes engineering studies and process validation protocols and summary reports (IQ/OQ/PQ, CSV and Test Method Validation).  • Develop /implement control plans consistent with product classification, potential defect types/frequency, severity, patient risk, process capability, process controls, etc.  • 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 (product/process)   • Assess the need for risk mitigation techniques • Assists in the development of manufacturing and inspection procedures. • Support the Manufacturing Organization in creation, review and release of MPI & Risk Management • 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 PROFESSIONAL EXPERIENCE REQUIREMENTS:  • 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  • Experience with Medical Device industry 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

 

OTHER REQUIREMENTS:  • Knowledge of MSOffice, 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.   

If you are interested for this great assignment for a major actor in the MD industry, feel free to contact me. 

Olivier.worch@randstad.ch

Or 0041 58 201 55 55

I am looking forward to your applications