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.
Knowledge / Education
· BS degree in engineering, a technical or scientific discipline; or equivalent 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