Process Quality Engineer

2 days ago


Scarborough, United States Tek Support Full time

Responsibilities:

  • Analyzes current "in house" raw material specifications to ensure appropriate features and limits are in place to support company manufacturing process.
  • Evaluates company initiated raw material changes and coordinates appropriate testing and validation as required.
  • Suggests and supports new methods or materials for continual improvement in the quality or efficiency of a product or process.
  • Works to reduce costs in all areas of manufacturing by analyzing current equipment for process suitability and provides detailed plans for improvement.
  • Creates and revises manufacturing documents, specifications, standard operating procedures (SOPs), safety instructions, validation protocols, risk assessments, and procedures and other technical documents to insure compliance, efficient and safe procedures.
  • Conducts Quality Investigations to identify root-cause of indentified production issues
  • Works cross functionally to support real time production quality issues related to materials
  • Authors material handling procedures for quarantined products based on quality issues


Basic Qualifications | Education:

  • Bachelor's degree (BS) in Engineering or equivalent combination of education and experience.
  • Minimum ten years engineering experience in a controlled manufacturing environment.
  • Experience working in a GMP, FDA, ISO and USDA regulated environment.
  • Knowledge of Database software; AutoCAD Design software; Development software; Internet software; Inventory software; Manufacturing software; Project Management software; Microsoft Excel software and Microsoft Word software.


Preferred Qualifications:

  • Experience with cGMP and ISO 13485 regulations and practices.
  • Experience in design/build, automation, PLC programming, equipment troubleshooting.
  • Experience with statistical analysis software (Minitab).



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