Lead the quality engineering team to get Global Quality Objectives.
Identify Manufacturing process defects (scrap, nonconforming material, customer complaints) by dispositioning non-conforming material, assisting in identification of primary root causes and understanding corrective and preventative actions. May be responsible for working with process owner to bound product stops and document release criteria.
Understanding of product quality plans, documents and systems by reviewing product specifications, quality specifications, and working with quality systems. May be responsible for learning risk analyses and FMEAs.
Monitoring Systems by becoming familiar with systems applications and critical process steps; and through familiarization with methods used to reduce process variation.
Become familiar with Product/Process improvement efforts by understanding current quality metric data and learning the various analysis methods used to enhance sustaining product design and new product development
Learn Quality Tools & Training Materials by gaining knowledge of prevalent tools used and by reviewing & utilizing available training materials.
Lead, check and provide support in the execution and investigation of CAPAs, NCEP, Failure Mode Investigations, etc.
Responsible for reviewing and developing process validation protocols and reports. Support other functional areas during the validation activities: run and / or review and / or approve protocols/ reports IQ 's, OQ' s and PQ 's as well as any other document relating to validation.
Read, understand, and interpret technical drawings, procedures, and protocols
Assure that all laboratory equipment is in compliance to perform the analysis activities (calibration, safety, cleanness).
Document investigation findings in analysis report on GCS2
Become a trainer for the Software related with complaints handling process (GCS2), as required.
What we're looking for:
Bachelor or Licenciature degree in Chemical, Industrial, Electronic, Biotechnology, Electromechanical Engineering or Related Field.
English Level desired: 80-89%
Experience: At least 5 years
Technical Competencies: Desirable ASQ Certified, ASQ certification (CQE, SSGB) desired, Problem Solving, Formal training on statistical and quality techniques desirable, Knowledge of QSR’s, Networking, ASQ Certified.