Quality Engineer - Sterilization

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Milwaukee, WI
$100,000 - $110,000
Job Type
Direct Hire
Oct 03, 2018
Job ID
We are searching for a quality engineer with expertise in the sterilization process for medical devices for a medical device manufacturing site in the southern Milwaukee suburbs.  The The Quality Quality Engineer - Sterilization will be primarily responsible clean room qualifications, environmental monitoring program for clean rooms, cleaning process, sterilization process, Internal audits, as well as and assigned new product development programs and quality system related projects.  The Quality Engineer - Sterilization will also:
  • Act in the role as subject matter expert and technical advisor on clean room environment, monitoring and sterilization process ( sterilizer IQ, OQ and PQ validation )
  • Develop, implement, manages and improve the environmental monitoring process.
  • Support new product development activities n in the development of master validation plans, PFMEA’s, control plans, procedure and process development
  • Support investigation and resolution of NCRs and CAPAs.
  • Assist in other CAPA activities as directed, including complaint failure investigations and customer communications.
  • Management of outsourced laboratory services
  • Maintains current knowledge of ISO 13485 and FDA QSR , Sterilization principles, ISO 14644 requirements
  • Analyzes inspection and testing processes, mechanisms and equipment.
Requirements for Quality Engineer - Sterilization
  • Bachelor's degree in a scientific or technical discipline
  • 5+ years experience in the medical device Industry
  • Mastery knowledge of ISO 13485:2003, ISO 14644,  FDA 21 CFR Part 820 and Sterilization Principles
  • Experience with Statistical Process Control and Process Validation.
  • Certified Quality Engineer (ASQ) (preferred)
  • Experience with Process, Product and/or Software Validation
  • Excellent statistical and quantitative skills and a track record of managing multiple competing priorities