Quality Engineer - Medical Devices

Expiring today

Recruiter
Career Brokers
Location
Hartford
Salary
Competitive
Posted
Sep 21, 2016
Closes
Sep 29, 2016
Industry
Manufacturing
Employer Type
Direct Employer
Employment Type
Permanent
Hours
Full Time
Quality Engineer - Medical Devices

Leading medical devices contract manufacturer seeks a quality engineer to lead quality assurance projects supporting both new product development and the transfer of new products to manufacturing. This dynamic company develops and manufactures Class II and Class III medical devices. This company offers the opportunity to work on a on a wide range of devices, with lots of customer interaction.

The Quality Engineer will support:
  • Quality engineering for new product development
  • Product quality management for product transfer to manufacturing
  • The development and management of the validation master plan
  • The development of protocols, performance of statistical analysis and validation standard operating procedures
  • IQ, OQ, PQ
  • Support production as CAPA system owner
  • Investigate and resolve CAPAs
  • Evaluate vendors and suppliers from a quality standpoint
Requirements:
  • Bachelors degree; preferably in engineering or a technical discipline
  • 4+ years progressive quality engineering experience in Class II or Class III medical devices
  • Experience running CAPAs preferred
  • Excellent analytical skills and a depth of experience with statistical analysis
  • Excellent communications skills; oral, written and electronic
  • A track record of accomplishment in prioritizing and running multiple quality assurance projects
  • CQE preferred
  • Lean Six Sigma training and/or certification preferred