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.
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!
Skills Required
- Bachelor’s degree in engineering, a technical discipline, or a scientific discipline, or equivalent education and experience
- 5–10 years of experience in an FDA-regulated environment, automotive industry, or semiconductor industry
- Experience in quality within an FDA-regulated industry, including QSR and ISO 13485, or experience in automotive or semiconductor industries
- Experience with FDA and ISO 13485 certification inspections or IATF 16949 certification audits
- Experience managing and supervising diverse teams, preferably as a Quality Manager
- Direct experience with reject and defect monitoring and improvement activities
- Experience with statistical techniques, process improvement, and Design of Experiments
- Effective verbal communication and excellent technical writing skills
- Ability to communicate at multiple organizational levels
- Ability to organize and prioritize effectively
- Ability to generate and maintain organized, accurate records
- Knowledge of engineering principles using statistics and Statistical Process Control tools
- Personal computer skills, including word processing, spreadsheets, and databases
- Ability to work effectively in a high-stress, high-energy environment
- Ability to make effective decisions quickly using vague or imperfect information
Insulet Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Insulet and has not been reviewed or approved by Insulet.
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Healthcare Strength — Healthcare coverage is broad, including medical, dental, vision, life and disability insurance, wellness resources, and an EAP. Plan details are described as comprehensive, with PPO options and first-day eligibility noted in some cases.
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Retirement Support — Retirement programs include a 401(k) with a company match equal to 50% of the first 6% of pay, with vesting after a year. This match is paired with other financial benefits and is characterized as a strong element of the package.
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Equity Value & Accessibility — An ESPP with a 15% discount and a look-back enables stock purchases at 85% of the lower offering-period price. This feature is presented as a notably attractive wealth-building benefit.
Insulet Insights
What We Do
Insulet Corporation, 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 disposable Pod provides up to three days of non-stop insulin delivery, without the need to see or handle a needle. Insulet also leverages the unique design of its Pod by tailoring its Omnipod technology platform for the delivery of non-insulin subcutaneous drugs across other therapeutic areas. Founded in 2000 (NASDAQ: PODD), Insulet operates with a customer-centric focus to supply high-quality products and expand the use of insulin pump therapy. Omnipod products are now available in 20+ 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
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