Church & Dwight - Tiffin, OH

posted 7 days ago

Full-time - Mid Level
Tiffin, OH
Chemical Manufacturing

About the position

The Quality Engineer will lead the continual improvement program, oversee process validations, and host customer audits while ensuring compliance with FDA Regulations, Global Food Safety Initiative (GFSI) Standards, and customer requirements. This role involves coordinating GFSI activities, ISO 9001:2008 certification, and Quality Management Systems between the Old Fort and Green River Plants, focusing on quality systems and process improvements.

Responsibilities

  • Lead the Plant Continual Improvement/Executional Excellence Programs using capability studies for product/process improvements and Lean Six Sigma processes.
  • Ensure Quality Systems comply with requirements outlined in the C&D Global Quality Manual, ISO 9001:2008, GFSI Standards, and FDA cGMP regulations.
  • Oversee the internal audit program monitoring plant quality systems to support the plant 'audit ready' goal.
  • Conduct and lead quality and customer complaint investigations.
  • Host customer audits, provide audit responses, and ensure completion of follow-up corrective actions for all identified non-conformances.
  • Apply Quality Engineer skills to oversee the plant validation program and perform Statistical Process Control (SPC) tests.
  • Interact with Corporate Brand Teams and R&D Groups on new products and product improvements.
  • Execute Corporate Quality Initiatives in the plant, including responsibility for implementing the Technology Transfer Process.

Requirements

  • BS/MS degree in related field (Quality Engineering certification desirable)
  • Minimum of 5 years quality experience in the consumer products, medical device, and/or pharmaceutical industries.
  • Knowledge of cGMPs, 21 CFR Part 110, 210/211 or Global Food Safety Initiative Standards, and HACCP.
  • Experience working in a plant environment.

Nice-to-haves

  • Lean Six Sigma Green Belt preferred; Black Belt a plus
  • Trained auditor in GMP, and ISO 9001 or ISO 13485 a plus.
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