Quality engineer
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.
* knowledge of sampling distributions, binomial, poisson, normal and exponential distributions and be able to apply statistical inference in each.
* 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.
* apply and incorporate risk management techniques throughout the product life cycle.
* 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.
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