Descripción del puesto

About the job

Important international company is looking for a Validation Engineer with experience in the Medical Devices industry. (9 month project with the possibility of extension)

Technical/Functional Skills

• Knowledge of Medical Equipment manufacturing processes
• GMP (Good Manufacturing Practices) & ISO (International Organization for Standardization) 9000 and regulatory affairs
• Ability to specify & qualify Assembly, Tooling, Gage equipment and Fixture equipment
• Knowledge in the areas of Process validation, Statistical process control, Product design & DFMA (Design for Manufacturing & Assembly), Plastic & metallic materials & processing and Applied Statistics
• Knowledge of drawing software system such as AutoCAD and Solidworks.
• Demonstrated ability to interpret the engineering drawings i.e., GD&T (Geometric Dimensioning &Tolerancing)
• Knowledge of productive processes.
• Ability to work and interact with co-workers to accomplish company goals in a team environment
• Ability to work in stressful/fast paced environment

Responsibilities:

• Conduct meetings to develop strategies and solutions with a cross functional team
• Can guide on the Validation process, lead the draft and review of protocols and test reports
• Can offer onsite support during the execution phase of validations (IQ, OQ, PQ).
• Can draft Validation Strategy, including TMV’s
• Can qualify first articles, complete process capability studies & process validation on both internal & supplier processes using appropriate statistical techniques
• Can support change management activities using organization PLM tool
• Prepare reports as per project requirement
• Can supervise, coordinate and technically revise the work of a limited group of technicians.
• Responsible for ensuring subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition
• Responsible for communicating business related issues or opportunities to next management level
• Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures
• Etc.

Requisitos

Necessary experience:

• 4 + years of experience & demonstrated proficiency in process/equipment validation & providing ongoing technical support is preferred with evidence of continued self-development.
• Work experience in the Medical Device industry.
• Advanced English

Beneficios

Cursos y certificaciones

9 month project with the possibility of extension

Location: Saret Industrial Park, Rio Segundo, Alajuela, Costa Rica.

Onsite, Business Hours