Position Overview:
Provides strategic direction and management support for Insulet Corporation’s quality system, quality teams and activities, and quality support for international commercial organizations, primarily in Europe, the Middle East and Asia Pacific.
Assures compliance with applicable quality management systems regulations and standards in applicable international geographies, and the execution of corresponding QMS activities.
Interfaces with other Insulet functions as well as with suppliers, partners, customers and other external parties on issues related to quality.
Responsibilities:
Serve as primary point of contact between Insulet’s international regional commercial organizations and the global quality organization and quality management processes. Serves as critical link in the communications between the larger QARA Team and the in-country and in-region commercial organizations for customer issues, escalations, etc.
Host and support commercial and regional focused audits (internal, notified body, regulatory agency).
Ensure Quality oversight of distributors, including Quality Agreements, auditing, training, performance monitoring.
Ensure that internal and external stakeholders in the regional commercial context understand and execute to post-market obligations (e.g., complaint handling, field actions).
Partner with the Global Product Monitoring team on execution of Field Actions as needed.
Partner with Global Quality Management Systems team to ensure regional QMS is suitable and compliant with local requirements.
Partner with Regulatory team to monitor, escalate, and adapt to changes regional regulatory landscape. Liaison with in-country and in-region industry associations and regulatory bodies.
Provide advice, oversight, and execution support for in-country or in-region labeling requirements, as needed (e.g., license numbers, NB numbers, translation augmentation, etc).
Resource for in-country or in-region warehouse and distribution center oversight and partnership from Quality perspective.
Delivers Quality related insights from both country and regional perspectives to product and project teams, supporting market expansion efforts.
Provide oversight of regional CAPA process, chair regional CAPA Review Board, and ensure overall Regional CAPA system effectiveness.
Coordinates quality activities supporting international market expansion.
Measure and evaluate quality system effectiveness with emphasis on preventive action. Suggest methods for improving product quality, documentation, and quality system processes.
Perform Quality System monitoring and analysis activities and publish management reports.
Monitor global quality metrics, analyze trends, and proactively identify areas for improvement. Execute respective site and regional commercial quality reviews and represent international commercial sites and regions at Global Quality Management Review.
Provide guidance, development, and direction of staff, both direct reports and dotted line reports.
Performs other duties as required.
Education and Experience:
Minimum Requirements:
Bachelor’s degree in life sciences, engineering, or related field and/or equivalent combination of education and experience.
Extensive experience in quality leadership roles and people management in the medical device industry, preferably active devices with disposable and durable components, mobile and cloud software applications.
Detailed knowledge of ISO 13485, and relevant quality system regulations and standards (EU MDR, UKCA, FDA (21CFR820, 803, 806), CMDR, TGA, etc.).
Expertise in global quality systems, international regulatory compliance, and cross-cultural team management.
Strong strategic thinking, communication, and stakeholder influencing skills.
Preferred Skills and Competencies:
Advanced degree preferred.
Certification in quality (e.g., ASQ, ISO 13485 Lead Auditor) or lean methodologies a plus
Strong leadership and analytical skills with team-focused attitude.
Self-starter with demonstrated ability to design, develop, and automate business processes.
Excellent interpersonal, verbal and written communication skills.
Comfortable in a fast-paced environment with minimal direction.
Ability to organize and judge priorities.
Ability to communicate and work effectively at multiple levels within the organization.
Advanced PC skills, word processing, spreadsheet, and database skills.
ASQ Certified Quality Manager (or equivalent) preferred.
Physical Requirements (if applicable):
Regional and/or international travel, up to 40%.
Flexibility in working hours to accommodate international time zones.
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. 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. For more information, please visit insulet.com and omnipod.com.
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!
Please read our Privacy Notice to learn how Insulet handles your personal information when you apply for a vacancy with us here.