Demo

Process Engineer (Quality)

TekOne IT Services Pvt. Ltd.
Scarborough, ME Contractor
POSTED ON 3/29/2025
AVAILABLE BEFORE 4/29/2025
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).

Competencies

  • Ability to be able to meet deadlines while working on multiple projects.
  • Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
  • Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations.
  • Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.

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