Manager, Quality Assurance Engineering

Job Summary

Resident in contract manufacturer (Suzhou, China) site, manages contract manufacture quality KPI. Deploy Insulet’s Quality programs, activities at contract manufacture site and govern its production.
Supporting current operations and new product introductions (design transfer to contract manufacturer). Manages Quality technical and engineering personnel. Interfaces with other Insulet departments (senior management, operations, engineering, R&D, etc.) as well as other external parties on issues related to quality.

Position Overview:
Resident in contract manufacturer (Suzhou, China) site, manages contract manufacture quality KPI. Deploy Insulet’s Quality programs, activities at contract manufacture site and govern its production.

Supporting current operations and new product introductions (design transfer to contract manufacturer). Manages Quality technical and engineering personnel. Interfaces with other Insulet departments (senior management, operations, engineering, R&D, etc.) as well as other external parties on issues related to quality.

Responsibilities:
• Maintain quality metrics at contract manufacturer site toward achievement of pre-defined quality goals. Ensure contract manufacturer compliance to FDA QSR, ISO 13485, and related standards, regulations, and requirements.
• Develop and/or manage quality programs/initiatives and ensure its deployment at contract manufacturer site.
• 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.
• 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.
• Performs other duties as assigned.

Education and Experience:
• BS degree in engineering, a technical or scientific discipline; and/or equivalent combination of education and experience.
• 5-10 years’ experience in the FDA regulated environment or automotive/semiconductor industries.
Minimum Requirements:
• Experience in Quality in an FDA regulated industry; experience with QSR and ISO 13485, or automotive/semiconductor industries.
• Experience with FDA and ISO 13485 Certification inspections or IATF 16949 Certification audit.
• Demonstrated experience managing and supervising diverse teams, preferably as a Quality Manager.
• Direct experience with reject / defect monitoring and improvement activities.
• Statistical techniques, process improvement efforts, and DOE experience is a plus.

Preferred Skills and 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.

Insulet started in 2000 with an idea and a mission to enable our customers to enjoy simplicity, freedom and healthier lives through the use of our Omnipod® product platform. In the last two decades we have improved the lives of hundreds of thousands of patients by using innovative technology that is wearable, waterproof, and lifestyle accommodating.