Job Title Quality Engineer
Job Type Full-Time Regular
Job Description

My client is a leading innovator in contract, full-service medical device development and manufacturing, providing innovative solutions from product concept to real life.

  • Total capability and turnkey approach
  • Market-relevant innovation
  • Unsurpassed speed to market
  • Convergence of 4 world-class companies

Defines, leads, teaches and collaborates on appropriate quality engineering and supplier quality practices to ensure continuous improvement of production processes that are consistent with established standards, competitive benchmarks, and highest customer satisfaction. Will handle supplier quality process and systems. Will handle process/product validation (IQ, PQ, OQ, ) and capability analysis. will teach analytic, problem solving and quality tools for risk assessment (i.e. PFEMA), testing, capability studies, DOE, process control and gage R&R studies. This position is a lead position in the technical area and will work with both internal and external customers, or suppliers.

With a Bachelor's degree (Engineering or related)  and 5-10 years minimum solid quality experience in a  machining environment.  Experience in all the quality tools including root cause analysis, PFMEA, FMEA, hypothesis testing, capability studies, DOE and SPC is needed for this position. Experience with basic principles associated with castings and CNC machining and production a real plus. Six Sigma Certification a plus.  Working knowledge of the ISO 13485, ISO 14971 and FDA 21 CFR standards and regulations. Contact me at your earliest convenience for more detail at my office 513-204-2301 or via email tcimino@executivesearch.net