Quality Engineer 1

Fresenius Medical Care North America; Reynosa; Presencial; USD 50,000 - 90,000; Jornada completa

Descripción de la vacante

An established industry player is seeking a Quality Engineer I to ensure the highest standards of product quality in the medical device sector. This role involves managing projects, evaluating customer complaints, and developing corrective actions while ensuring compliance with regulatory standards. The ideal candidate will possess a Bachelor's degree in Engineering and have experience in quality engineering, particularly in medical devices. Join a dynamic team where your analytical skills and problem-solving abilities will contribute to innovative solutions and continuous improvement in product quality. If you are passionate about quality assurance and looking to make a significant impact, this opportunity is for you.

Formación

• Bachelor’s degree in engineering required, preferably in related fields.
• Two years of experience in quality engineering or medical devices preferred.

Responsabilidades

• Complete projects with clear objectives and timelines.
• Support evaluation of customer complaints and corrective actions.
• Conduct data analysis using statistical tools.

Conocimientos

Problem solving

Root Cause Analysis

Technical skills

Analytical skills

Interpersonal communication

Mathematics

Bilingual English / Spanish

Educación

Bachelor’s Degree in Engineering

Herramientas

Statistical software

Quality tools

Descripción del empleo

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.