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Quality Engineer II

Quality Engineer II

MG STAFFING GROUPJuncos, PR, pr
Hace 11 días
Descripción del trabajo

Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product. Collaborates with engineering and manufacturing functions to ensure quality standards are in place. Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment. Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications. Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements. May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and / or research and development as they apply to product or process quality.

  • Other duties may be assigned.

Requirements

Minimum 4 years of experience in regulated manufacturing environments with emphasis on :

  • Risk Management Documentation : Proficient in creating and maintaining pFMEAs.
  • Process Validation & Equipment Qualification (excluding cleaning processes and laboratory equipment) :
  • Hands-on experience with URS, FAT, IQ, OQ, PQ, and TMV.
  • Manufacturing Investigations :
  • Experience investigating deviations or non-conformances in support of product disposition.
  • Defect Trend Analysis :
  • Skilled in assessing and tracking trends in manufacturing defects or rejects.
  • Design Transfer Activities :
  • Proven experience executing design transfer from R&D to manufacturing.
  • New Product Implementation :
  • Involvement in projects related to new product introduction, including validation of design requirements and definition of manufacturing controls (excluding Operational Excellence initiatives).
  • Technical Skills :
  • Basic knowledge of statistics, preferably with experience using Minitab.
  • Familiarity with validation strategy development, including requirements flow-down from design to manufacturing.
  • Bachelor Degree in Engineering completed.

    Willing to work 100% on-Site and weekends when necessary.

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    Quality Engineer • Juncos, PR, pr

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