Senior Quality Enginner
- Publicado el: 03-05-2022,
- por RESONETICS.
- Descripción de la Empresa: Manufacturing Medical Devices.
This Sr. Quality Engineer position will focus on Sustaining/Qualification activities and Process Control in the contract manufacturing of medical products in accordance with policy and procedures. It will support activities in at least three Company Sites, travelling between them as required.
Sustaining/Qualification responsibilities include the different activities from support the day-to-day operations to the customer quality relationship (e.g. documentation verification and translation, NCR’s, qualification protocols and reports if needed, data analysis, training activities, visual and dimensional testing, measurement equipment, among others).
Active participant who can manage multiple and dynamically changing Projects on time, while influencing change and compliance to Quality System requirements. Position requires skills in advanced Quality Engineering techniques including Problem Solving using Six Sigma methodology, Process Validations, Process Development and optimization, Gage R&R, reducing dependence on inspection, ISO 13485 and/or 21CFR820 compliance. This position shall have a deep statistical knowledge and willing to travel to other facilities of the company to develop Transfer Projects, support engineering and production activities in order to ensure they meet Quality Requirements.
- University degree on Engineering fields (e.g. Industrial, Mechanical, Chemical, other) or equivalent experience in Quality area or related field.
- At least 5 years of experience in Quality areas support. Experience with Medical Devices Manufacturing environment and proved experience on Transfer Projects for at least 2 years.
- Good communication skills, including communication with associates in other departments. Proficiency in both English and Spanish.
- Proficient with MS Word, Excel, PowerPoint, MS Project and Outlook.
- Knowledge of medical product quality assurance (including the requirements for test protocols and statistical techniques).
- Knowledge of applicable regulations and standards such as FDA QSR, ISO 9001/13485 and knowledge in the areas of V&V, manufacturing practices and statistical techniques.
- CQT (Certified Quality Technician), CQE (Certified Quality Engineer) or other certification related with quality field is a plus.
- Minitab user (intermediate).
- ISO 13485 Internal Auditor Certified.
- Advanced statistical analysis skills.
Alajuela, Alajuela, Costa Rica
Sin Estudios Formales
No sabe Computo / No Aplica