Hi - Quality Engineer (Mexicali)

Descripción y detalle de las actividades

Support QA department on defining and scheduling internal audit calendars and frequencies based on risk level of the processes and communicate the dates to the stakeholders, as well as supporting on external audits.

Lead and support the audit preparation and execution, trend analysis, root cause analysis and implementation of corrective actions.

Develop solutions to identified problems and coordinate multi-disciplinary team members to achieve the goals in timely and effectively manner. Use of quality and continuous improvement tools and methodologies for problem solving (Ishikawa, DOE, DMAIC, 8D, Pareto, Histogram, etc.) - Support risk management, operations and assure documentation and procedures are followed, updated and maintained as required by internal Quality Policies and related FDA/cGMPs guidelines.

Lead in the identification and completion of NC and CAPA activities, including CAPA investigations and c...