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Quality Technician

Acton, Massachusetts

Post Date: 03/14/2017 Job ID: 8076 Category: Professional

JOB SUMMARY:  Our client primarily manufactures Class I Medical Devices used for patient positioning in the Operating Room.  This role has Operations Quality Technician responsibility to support the production activities for these products.

 

ESSENTIAL DUTIES AND RESPONSIBILITIES – Other duties may be assigned:
  • Serves as QA technician for operational quality functions in production.
  • Routinely identify and assist in mitigation of product/customer risk.
  • Support QE and Manager to deploy efficient and effective corrections to quality problems in a manner that prevents their reoccurrence using our internal listening systems (ie Internal Audits, NCEs, and CAPAs).
  • Use a variety of different measurement equipment to inspect components/devices.
  • Facilitate the Tool/Fixture calibration/certification program.
  • Assist in NCMR activities.
  • Create, edit, and own applicable change control processes using ECO and Doc Change systems under manager guidance.
  • Lead small Continuous Improvement Projects.
  • Competent in Gage R&R studies

 

SUPERVISORY RESPONSIBILITIES:

•           N/A

 

QUALIFICATIONS:
  • The ability to work under the direction of Operations Quality Manager to resolve quality issues in a dynamic environment while flexing priorities day to day.
  • Quality Technician Medical Device experience preferred with strength in Operational Quality a plus.
  • Familiarity of QSRs, ISO 13485, and ISO Quality System Standards
  • Have good analytical & data decision making with sound problem solving skills.  Having experience using root cause analysis tools a plus.
  • Ability to partner & communicate well with internal customers, peers, as well as leadership positions.
  • Computer literacy skills in applicable programs to position (MS Office in Windows OS)
  • Green Belt certification in Lean Six Sigma a plus, or at least an understanding of DMAIC phased approach to problem solving.
  • Certified Quality Improvement Associate (CQIA) a plus

 

 

EDUCATION AND/OR EXPERIENCE:
  • Prefer 5+ years of related quality technician experience
  • Prefer some experience in a medical device or other FDA regulated industry required

 

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