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.
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.
We are looking for highly motivated, performance driven individuals to be a part of our expanding team. We do this by hiring amazing people guided by shared values who exceed customer expectations. Our continued success depends on it!
Insulet Corporation (NASDAQ: PODD), headquartered in Massachusetts, is an innovative medical device company dedicated to simplifying life for people with diabetes and other conditions through its Omnipod product platform. The Omnipod Insulin Management System provides a unique alternative to traditional insulin delivery methods. With its simple, wearable design, the tubeless disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. Insulet’s flagship innovation, the Omnipod 5 Automated Insulin Delivery System, integrates with a continuous glucose monitor to manage blood sugar with no multiple daily injections, zero fingersticks, and can be controlled by a compatible personal smartphone in the U.S. or by the Omnipod 5 Controller. Omnipod products are offered in 25 countries around the globe.
HIRING SCAM ALERT
Recently, individuals impersonating Insulet Human Resources members have offered fraudulent interviews and job offers to unsuspecting candidates. To help protect you from these scam artists, please be aware that:
• Insulet will never interview a candidate over RingCentral, similar messaging apps or social media (i.e. Google Hangouts, WhatsApp, Facebook Messenger, etc.), or via text message.
• Insulet will never send a company check or ask an applicant to pay a fee or purchase at home work/training materials in connection with an application for employment.
• Insulet will never provide excess money to an applicant and ask the applicant to write a check for repayment.
If you have any doubt about a job offer or any other communication purporting to come from Insulet, please reach out to us directly at 978-600-7000.
If you receive any type of communication on behalf of Insulet that seems inappropriate or suspicious, please report this activity to: www.iC3.gov or www.stopfraud.gov.
