Principal Quality Engineer

Tandem Diabetes Care Switzerland Sàrl

Tandem Diabetes Care, Inc., is a global insulin delivery and diabetes technology company which creates new possibilities for people living with diabetes, their loved ones, and their healthcare providers through a positively different experience and is based in San Diego, California. Together we are creating new possibilities for people living with diabetes, their loved ones, and the healthcare providers through a positively different experience. We’d love for you to team up with us to “innovate every day,” put “people first,” and take a “no-shortcuts” approach that has propelled us to become a leader in the diabetes technology industry.GROW WITH US:Tandem Diabetes Care creates new possibilities for people living with diabetes, their loved ones, and their healthcare providers through a positively different experience. We’d love for you to team up with us to “innovate every day,” put “people first,” and take the “no-shortcuts” approach that has propelled us to become a leader in the diabetes technology industry.STAY AWESOME:Tandem Diabetes Care is proud to manufacture and sell the Tandem Mobi system and t:slim X2 insulin pump with Control-IQ+ technology — an advanced predictive algorithm that automates insulin delivery. But we’re so much more than that. Our company’s human-centered approach to design, development, and support delivers innovative products and services for people who use insulin. Because many of our own team members live with type 1 diabetes, or have a loved one impacted by diabetes, the work is personal, and we are committed to the cause. Learn more at tandemdiabetes.comA DAY IN THE LIFE:The Principal Quality Engineer is responsible for building, overseeing and implementing all relevant processes and procedures within the specific country/territory (OUS) to ensure the quality and compliance of all products and activities released by the Company. Responsible for the development and implementation of quality plans that will result in short and long-term sustainable growth of the country’s specific business. Responsibilities include support to all supply chain activities, clinical team activities, marketing, commercial, GPMS, customer care, suppliers’ qualification, evaluation and monitoring. In addition, supports all activities related to NCs and CAPAs related to OUS activities. The Principal Quality Engineer will interact with the department staff to determine quality system requirements and provide quality support to drive the continuous assessment and improvement of processes to ensure compliance with applicable regulations set by the International Regulatory Agencies.Responsible for compliance in line with international, country-specific, and regulatory requirements, such as EU MDR, MDSAP, FDA, ISO 13485, MEDDO, UK MDR and GDPR.Oversee market authorization requirements for product distribution (OUS).Interpret regulations/standards and develop compliance strategies.Develop, implement, and maintain processes to ensure compliance with regulatory requirements.Recommend methods for improved work processes, detailing process strengths and answering supplier and internal customers’ questions to gain group consensus.Responsible for improving reportable metrics in monthly Operational and Quality meetings.Manage, lead and/or oversee supplier audits to meet company, quality, and regulatory requirements, including country-specific requirements for the suppliers; responsibilities extend to audits performed by 3rd party contractors.Partner with domestic and international and marketing teams, and other departments as needed, to identify the requirements for qualification, management, and monitoring of suppliers.Partner with Legal, Regulatory, process owners and suppliers to create and revise Quality Agreements, as needed.Qualify, manage, and monitor supplier performance per Tandem supplier management approved processes. Identify gaps in current processes to develop, define, establish, and document new processes, as needed.Oversee suppliers, as needed, to ensure their performance is acceptable.Ensure CAPA/SCAR resolution without undue delay for suppliers, including timeliness of responses and action plans.Track internal matrix trends (complaints/NCR/Internal audit) and suggest process improvements based on observations or provide quality input to CAPA process.Analyze supplier information and present supplier metrics in appropriate meetings, including internal and supplier managed meetings.Develop, implement, and manage supplier audit tools, including performance evaluation methodology and metrics, as needed.Participate and support country/distributor quality and business reviews, including presenting data and metrics.You're Awesome At:Demonstrated depth and breadth knowledge of quality engineering and quality systems.Proficient knowledge of quality standards: ISO 13485, 21CFR Part 820, MDR and MDSAP and other appropriate industry standards.Advanced knowledge and application of principles outlined in Good...