Quality Engineer 1

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.
• 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.