Evenflo Feeding Inc. is seeking a Quality Engineer for their West Chester, OH (Cincinnati, OH area) facility.
The Quality Engineer is responsible for the safety, quality, and reliability requirements of Evenflo Feeding, Inc. products and confirming that these requirements are built into the product, as demonstrated through product verification and validation testing. This role is responsible for creating Product Integrity test specifications for each platform and product line, which includes medical device and consumer products. In addition, the Quality Engineer is responsible as an advocate for the consumer and anticipate customer needs, as well as investigate complaints from consumers through Evenflo ParentAlly and retail/institutional channels, including web-sites and blogs. The PI Engineer is responsible to follow up on consumer quality issues, determine root cause and track corrective actions.
BS in Engineering required (ME/EE/1E/Bio-Medical or equivalent degree, Bio-Medical preferred).
2+ years Quality Assurance or Product Development preferably with medical devices, consumer goods, or juvenile products.
Demonstrated working knowledge of Quality Tools (Quality Planning, Statistics and Probability, GR&R, capability analysis, Fishbone, 5 why, etc.).
Hands-on problem solving approach and able to prioritize competing tasks, as appropriate.
FDA Regulations (21 CFR 820), ISO 13485, and CPSC Regulations.
Able to read and understand industry standards (FDA, ASTM), product specifications, and drawings.
FDA medical device inspection experience is preferred.
Canadian Medical Device Regulation experience is preferred
Microsoft Office Suite and Web based systems. 3-D CAD software or equivalent preferred. Minitab or equivalent statistical software preferred.
Six Sigma Green Belt and CQE is preferred.
ISO auditor certification is preferred.
Excellent written and verbal communication skills.
Bilingual or multilingual is a plus (prefer Spanish, Mandarin and/or Cantonese Chinese, or Thai)
General product design, mechanics of materials, plastics, and plastic molding.
About Evenflo Feeding, Inc.
Located in the Greater Cincinnati area, Evenflo Feeding, Inc. designs, develops, manufactures and markets all ages and stages of infant and toddler feeding products. The Evenflo brand enjoys a 97% brand awareness among its target consumers and is, at its core, synonymous with baby feeding for over 90 years. Evenflo Feeding, Inc. was acquired in 2012 by Kimberly-Clark de Mexico, one of the world’s largest providers of consumer goods, including juvenile/baby & child care consumer packaged goods. Learn more about Evenflo Feeding, Inc. (EFI) at www.evenflofeeding.com.