SECTION 1: JOB SUMMARY* · Provide overall support to engineering activities.
· Provide support during validation activities andwriting the documentation.
· Responsible for engineering purchases throughdifferent purchasing platforms
SECTION 2: DUTIES & RESPONSIBILITIES*
Responsibilities mayinclude, but are not limited to:
· Perform NCR lifecycledocumentation and investigation, using statistical concepts.
· Provides technical supportto identify the causes for non-conformances and process failures and toimplement corrections thus assuring process performance and compliance againstEthicon’s QSR, GMP and ISO requirements for the manufacturing process.
· Performs non-conformanceinvestigations including NCR origination, bounding, product control, failureinvestigation, correction, and documentation with the non-conformance system.
· Support engineers inperforming validation activities, execution of protocols, engineering studiesand documentation.
· Help to Write engineeringdocumentation (protocols, procedures, special instructions, reports, etc.)
· Supports the documentationchanges in compliance with Ethicon’s Change management system.
· Engineering support in thecompletion of projects mainly focused on quality improvements, cost/scrapreduction, increased capacity and New Products.
· Conduct robustinvestigations. Analyzes data and recommends actions for process, equipment andsystem improvement.
· Ensure compliance to thequality policy in all activities.
· Ensure safe workingconditions and practices in the department as well as providing support on theplan safety requirements.
· Enable proactive approachfor process performance and customer satisfaction driving appropriate actionsacross all levels of the organization.
· Acts in accordance withsafety regulations and procedures.
· Supports internal andexternal audits and inspections.
· Submit purchase requisitionsfor Engineering department.
· Support Project SpendingManagement.
· Other responsibilities maybe assigned and not all responsibilities listed may be assigned.
From 4 to 6 years of experience inrelated fields.
Or currently pursuing anEngineering Bachelor’s Degree with half of School credits completion
Aminimum of High School Diploma or equivalent is required and EngineeringBachelor’s Degree complete or in progress.
·Computer skills:Excel (including charts/graphs), Word, Internet Explorer.
·Experience inmedical device manufacturing environment. (Preferred)
·Knowledge onmedical product and process design concepts such development, materials,standardization science and basic statistics. (Preferred)
·Knowledge of wordprocessing, spreadsheet analysis, presentation graphics, some engineeringanalysis and some statistical software (Minitab preferred).
·Analyticalthinking to provide and lead product inquiry investigations.
·Ability to workin cross-functional team to complete projects, knowledge in PE tools such asKaizen
·Ability to solvebasic problems using FI methodologies such as Five Whys, 5Ms, and others.
·Strongcommunication and interpersonal skills.
·Entailssignificant interaction with technical peers and manufacturing associates.
·Self-motivatedand capable of completing job duties with limited supervision
E.E.S., S.A. de C.V. Mexico (8283)