The Quality Engineer requires experience and skill in driving standardization, consistency, and improvement of quality systems and GMP’s across all shifts in their functional area of responsibility, including special projects. This position is a key leader who provides direction, support, leads projects, drives consistency, and leads problem solving for areas associated with plastics injection molding equipment.

DUTIES AND RESPONSIBILITIES:
This position will be responsible for the quality process including critical process characteristics, standards, audits, complaint resolutions, training
• Integration of quality systems to ensure a common quality system throughout the North American Plant locations.
• Provide manufacturing personnel with quality systems and tools to allow effective evaluation of products and processes.
• Ensure the application of advanced quality tools to provide process improvement to the manufacturing group.
• Ensure that quality tools and system training are adequate to meet the company’s quality goals.
• Formulate and maintain accurate Quality Documentation including policies and procedures.
• Provide leadership and direction to the team to enable them to perform their tasks.

•  This position will report directly to the Quality Manager.
  • This is a high visibility role opportunity to work closely with manufacturing, customer service and other quality professionals to problem solve and support new and existing projects. 
  • Lead and manage indirect reports within the facility to meet or exceed targets and objectives set by the established standards as related to the quality management systems.
  • Demonstrate examples of working with sterile sealing and environmental monitoring. 
  • Proactive review of improvement of systems and process to ensure maintenance of Quality Standards.
  • Conduct medical device reporting and assessments and process improvements.
  • Investigate moderately complex manufacturing product quality and compliance issues (e.g. CAPA, non-conformances, audit observations) in design and production processes prior to final product customer release. Make recommendations and confirm results
  • Assist in the development and initiate standards and methods for inspection, testing, and evaluation, utilizing quality engineering analytical tools. Formulate quality assurance policies and procedures.
  • Meet with all levels and departments within the factory to discuss results and recommend solutions.
  • Follow all procedures and SOP’s for the facility i.e., LTTV, GMP rules, etc.
  • Be aware of hazardous materials in the area and the proper handling of hazardous materials. Awareness will be achieved through training, MSDS review, safety meetings, and toolbox meetings.
  • Be aware of, understand, and follow emergency procedures.
  • Report all spills or other environmental incidents following EHS protocol.
  • Must follow all rules and comply with mandatory Job-Observations, IFE’s, IFO’s, Walkabouts, Monday Reports, Quality training, monthly awareness training and any required departmental training/projects on time without supervision.
  • Participate in investigations of environmental incidents.
  • Be alert to and welcome new learning opportunities. Always try to increase education/training.
  • Ensure that (where applicable) the supply chain is made aware of their food safety obligations
  • partner in the quest to deliver a safe product to the consuming public.