Quality Engineering Manager
Insulet Corporation / Neighborhood Diabetes - Bedford, MA

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Job Description:
Position overview: Manages Insulet’s Quality programs,
activities, and responsibilities supporting current
operations and new product introductions. Manages
Quality technical and engineering personnel. Interfaces
with other Insulet departments (senior management,
operations, engineering, service, etc.) as well as with
suppliers and other external parties on issues related
to quality.
JOB / DUTIES / RESPONSIBILITIES (Listed in order of
importance)
  • Manage quality assurance toward achievement of quality
goals. Establish and maintain company compliance to FDA
QSR, ISO 13485, CMCAS and related standards,
regulations, and requirements.
  • Develop and/or manage quality programs and training.
Establish reliability testing lab to recreate failure
conditions.
  • Review data and information and make accept/reject
decisions about Products, Processes, Validations, etc.
  • Maintain and track quality for the purposes of
analysis, control, cost and management reports.
  • Investigate product defects, rejects and systems
failures with emphasis on corrective action. Provide
hands-on leadership to implement failure analysis and
corrective actions.
  • Maintain accurate, timely and efficient inspection and
/ or complaint processing labs.
  • Manage effective Material Review Board meetings assure
timely disposition and effective corrective action.
  • Manage Calibration activities and assure
appropriateness of tooling, fixturing and equipment
selection.
  • Suggest methods for improving product quality, design,
or manufacturing processes.
  • Serve as a team member to provide quality engineering
expertise to product development, improvement, or other
teams.
  • Assist with failure and hazard analysis for commercial
product, and components.
  • Supervise quality assurance engineers, inspectors, or
other personnel.
  • Other duties as assigned.
JOB QUALIFICATIONS
Requirements
Knowledge / Education
  • BS degree in engineering, a technical or scientific
discipline; or equivalent experience.
Job Experience
  • 5-10 years experience in the FDA regulated environment
  • Experience in Quality in an FDA regulated industry;
experience with QSR and ISO 13485.
  • Experience with FDA and ISO 13485 Certification
inspections.
  • Demonstrated experience managing and supervising
diverse teams, preferably as a Quality or Operations
Manager
  • Direct experience with reject / defect monitoring and
improvement activities
  • Statistical techniques, process improvement efforts,
and DOE experience is a plus
  • Experience with ETO sterilization methods preferred
Skills / Competencies
  • Effective verbal and excellent technical writing
skills. Ability to communicate at multiple levels of an
organization.
  • Ability to organize and judge priorities.
  • Excels at generating and maintaining organized and
accurate records.
  • Knowledge of Engineering principles using statistics
and SPC tools.
  • PC skill, word processing, spreadsheet, database.
  • Able to work effectively in a high-stress, high-energy
environment
  • Able to make effective decisions quickly based on
vague or imperfect information
Division/Department : Insulet Corporation

Insulet Corporation / Neighborhood Diabetes - 22 months ago - save job - copy to clipboard