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**
Tipo de puesto: Tiempo completo
Idioma:
- English (Obligatorio)