*quality engineer i*
*responsibilities*:
- completes projects as assigned by the department manager.
must be able to prioritize responsibilities and establish time lines in order to maintain a balance of support in all projects and execute projects with clear objectives.
communicates project deliverables, objectives, and timelines to team members.
- utilize established procedures to perform routine assigned tasks under close supervision.
- support the evaluation of customer complaints along with the development of corrective/preventive actions/corrections (capa/nc).
- monitor internal nonconformance (nc) and assist developing corrective and preventive actions as part of the quality team.
- responsible for making regular walkthroughs throughout the manufacturing area in order to develop and/or participate in projects for process improvement and the overall quality of the product.
- responsible for the development and implementation of test methods for medical devices and equipment.
- assist the different departments in validations of product, processes as well as on the writing of the validation protocol when needed.
- analyze data with statistical software and quality tools such as risk analysis, flow charts, control charts, scatter diagrams and histograms.
- conducts correlation and regression analysis, experimental design (doe) and acceptance sampling; as well as conducting and interpreting gage r&r studies.
- ensure regulatory compliance to cgmp's of all medical device regulatory agencies (i. e fda, iso and mdd) providing proper documentation corporate regulatory on evaluation and analysis on customer complaint samples as well as fir's when required.
- participate in conference calls, presentation and meetings with internal departments, cross site teams and upper management when required.
- maintain constant communication with corporate qe/pss, canada or other fmc sites in relation to capas, overall quality improvement projects and customer complaints when required.
- this position will be required to support and respond to internal/external audit observations and corrective actions.
- support new design transfer activities, engineering changes and savings projects.
- initiate and participate in change control activities.
*qualifications*:
- bachelor's degree required, preferably in mechanical, industrial, electrical, electromechanical, biomedical or any other equivalent engineering degree.
- two years of experience in quality engineering or related field (medical devices preferred).
- excellent interpersonal, verbal and written communication skills.
- must have good technical and analytical skills.
- ability to understand and employ mathematics at an engineering or scientific level.
- strong computer skills.
- ability to effectively present information to upper management and other groups.
- problem solving and root cause analysis.
- knowledge of six sigma methodology.
- responsible of providing the necessary engineering support and developing process/product/quality improvements and controls to assure a high confidence on the final finished product.
- ability to develop and implement new methods as well as the usage of statistical tools to solve quality problems and detect process behaviors.
- should practice a customer-focused quality approach.
- perform process capability studies.
- bilingual english / spanish.
- u.s.a visa required.