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Manufacturing Engineer

3 months ago

Arlington, United States Novozen Healthcare LLC Full time

Title: Manufacturing Engineer - HIGH PRIORITY

Location: Arlington, TN (Onsite)


  • Advocates and leads design for manufacture and assembly through technical leadership and direction in quality assurance and quality control
  • Supports the development and introduction of new products, processes, and technologies, with focus on quality systems development, regulatory compliance, and process risk management including pFMEA.
  • Will support the design of robust inspection strategies including CQA’s, CTQs and MSA’s to enable process risk identification, process characterization, capability and robust process control.
  • Proficient in risk management practices and tools, having high expertise in failure modes associated with production and production related processes, (PFMEA).
  • Ensure all Risk Management outputs comply with ISO1497
  • Provide manufacturing quality engineering support for the execution of quality assurance activities during design transfer phases of new product development.
  • Support the required stages defined in the product and process design cycle ensuring compliance with the current design control and transfer regulations and policy.
  • Develop Measurement System Analysis (MSA) strategy and approve executed MSAs
  • Support the development, execution, and approval of validation strategies, with the goal of highly capable processes, that result in high yield and enable scalability. Approve protocols and reports, including data analysis.
  • Apply appropriate statistical techniques to ensure the development of robust, predictive quality systems which are easily transferable and maintainable in a production environment.
  • Lead the supplier qualification strategy and approve the supplier validations and Production Part Approval Process (PPAP).
  • Communicate effectively with all internal customers, stakeholders, and project teams to deliver successful project transfers with the highest levels of quality that meet the NPI project goals.