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
JOB / DUTIES / RESPONSIBILITIES (Listed in order of
goals. Establish and maintain company compliance to FDA
- Manage quality assurance toward achievement of quality
QSR, ISO 13485, CMCAS and related standards,
regulations, and requirements.
Establish reliability testing lab to recreate failure
- Develop and/or manage quality programs and training.
decisions about Products, Processes, Validations, etc.
- Review data and information and make accept/reject
analysis, control, cost and management reports.
- Maintain and track quality for the purposes of
failures with emphasis on corrective action. Provide
- Investigate product defects, rejects and systems
hands-on leadership to implement failure analysis and
/ or complaint processing labs.
- Maintain accurate, timely and efficient inspection and
timely disposition and effective corrective action.
- Manage effective Material Review Board meetings assure
appropriateness of tooling, fixturing and equipment
- Manage Calibration activities and assure
or manufacturing processes.
- Suggest methods for improving product quality, design,
expertise to product development, improvement, or other
- Serve as a team member to provide quality engineering
product, and components.
- Assist with failure and hazard analysis for commercial
- Supervise quality assurance engineers, inspectors, or
- Other duties as assigned.
Knowledge / Education
discipline; or equivalent experience.
- BS degree in engineering, a technical or scientific
experience with QSR and ISO 13485.
- 5-10 years experience in the FDA regulated environment
- Experience in Quality in an FDA regulated industry;
- Experience with FDA and ISO 13485 Certification
diverse teams, preferably as a Quality or Operations
- Demonstrated experience managing and supervising
- Direct experience with reject / defect monitoring and
and DOE experience is a plus
- Statistical techniques, process improvement efforts,
Skills / Competencies
- Experience with ETO sterilization methods preferred
skills. Ability to communicate at multiple levels of an
- Effective verbal and excellent technical writing
- Ability to organize and judge priorities.
- Excels at generating and maintaining organized and
and SPC tools.
- Knowledge of Engineering principles using statistics
- PC skill, word processing, spreadsheet, database.
- Able to work effectively in a high-stress, high-energy
vague or imperfect information
- Able to make effective decisions quickly based on
Division/Department : Insulet Corporation
Insulet Corporation / Neighborhood Diabetes - 2 years ago