Quality Engineer

Oliver Tolas Healthcare Packaging

About The Position

The Quality Engineer is responsible for leading projects to continuously improve the quality of our products and processes. Working as a project leader and internal consultant the QE works closely with department managers and team leaders to define improvement targets, measure and analyze process capabilities, perform root-cause analysis projects, implement improvements and control ongoing performance. Responsible for the quality system, customer concern processing and supporting development/production processes. Essential responsibilities include the following, other duties may be assigned:

Requirements

  • Bachelor's degree (B. S.) from four-year college or university in Engineering, Statistics or related field; or four years related experience and/or training; or equivalent combination of education and experience
  • Strong analytical skills including the use of simple and complex quality tools.
  • Working knowledge to perform and lead kaizens.
  • Solid verbal and written communication skills.

Nice To Haves

  • Deep software skills including, MS Office, ERP, and Statistica, MiniTab, or related statistical analysis tool.
  • Background in Total Quality Management (TQM), FDA Good Manufacturing Practices (GMP), and ISO 9000 concepts.
  • Certification or specialized training in Statistical Process Control (SPC) and Design of Experiments (DOE).

Responsibilities

  • Create and maintain design and process risk analysis (e.g., FMEAs). Work with Operations, Engineering, Supply Chain and Sales on risk mitigation activities.
  • Identify and report quality related trends and develop processes/systems to detect those trends proactively and respond accordingly to improve product and process quality.
  • Lead the implementation of standard quality systems/processes for the detection, control, and remediation of production quality issues.
  • Initiate capital investment requests or other strategic activities to improve product and process quality.
  • Works with Operations, Engineering, Supply Chain and Sales to coordinate and lead cross functional efforts to address quality concerns or drive improvement in current performance.
  • Works directly with customers on quality concerns including response to issues and conflict resolution.
  • Teach and coach best practices in problem solving, root cause analysis, statistical quality control, and authoring work instructions.
  • Participate in internal audit system and provide assistance to teams in resolving corrective actions.
  • Support quality improvement projects as deemed necessary by the organization.
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