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’
, 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
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
, such as EU MDR, MDSAP, FDA, ISO 13485, MEDDO, UK MDR and GDPR. Oversee market authorization
for product distribution (OUS). Interpret regulations/standards and develop compliance strategies. Develop, implement, and maintain processes to ensure compliance with regulatory
. 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
, including country-specific
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
for
, 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 Manufacturing Processes (GMP). Previous experience generating and analyzing quality metrics. Advanced knowledge of and demonstrated experience using problem solving methodologies: why-why analysis, fault tree analysis, cause and effect diagram etc. Ability to recognize non-conformances from accepted and documented practices. Skilled at clearly conveying in-depth knowledge to all levels within, and outside of, the organization. Skilled at effectively communicating department or area issues and results within and across functional areas and conducting presentations of technical information concerning specific projects or timelines. Able to gain cooperation of others. Ability to objectively evaluate situations and make recommendations for changes considering overall project demands. Must be able to explain audit results and influence other's understanding of audit observations in a culturally sensitive, tactful, and professional manner. Experience with International Relations, preferred. Experience with distributors and importers, preferred. Extra Awesome:Bachelor’s degree in engineering, preferably Mechanical Engineering or the equivalent education and applicable work experience. ISO lead auditor certification or equivalent, preferred. 10 years of related experience in the field including:Experience leading and partnering with a quality assurance team through the various stages of development, from small startup organization to large organization. Experience supporting US and international regulatory authorities or notified bodies. Experience conducting internal audits. WHY YOU’LL LOVE WORKING HERE:At Tandem, we believe joy fuels excellence. That's why we've built a workplace that celebrates your achievements and supports your well-being. Our team thrives on pushing boundaries and fostering growth, all while maintaining a spirit of fun and camaraderie. This is just one of the ways we stay awesome!BE YOU, WITH US!We embrace the value that every single one of us brings to the table. But sometimes we forget that when we don’t meet 100% of a job description’s criteria – maybe you’re feeling that way right now? We encourage you to apply anyway. Because we want you to be you, with us. Tandem is firmly committed to being an equal opportunity employer and does not discriminate on the basis of age, disability, sex, race, religion or belief, gender identity or expression, marriage/civil partnership, pregnancy/maternity, or sexual orientation. We are an inclusive organization, and we welcome applications from a wide range of candidates. Selection for roles will be based on individual merit alone. REFERRALS:We love a good referral! If you know someone who would be a great fit for this position, please share!Make a move that matters. Join Tandem Diabetes Care, where we're turning challenges into triumphs every day and where your talents will help shape a healthier, happier tomorrow.
QUALIFICATIONS
, 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
QUALIFICATIONS
, 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 Manufacturing Processes (GMP). Previous experience generating and analyzing quality metrics. Advanced knowledge of and demonstrated experience using problem solving methodologies: why-why analysis, fault tree analysis, cause and effect diagram etc. Ability to recognize non-conformances from accepted and documented practices. Skilled at clearly conveying in-depth knowledge to all levels within, and outside of, the organization. Skilled at effectively communicating department or area issues and results within and across functional areas and conducting presentations of technical information concerning specific projects or timelines. Able to gain cooperation of others. Ability to objectively evaluate situations and make recommendations for changes considering overall project demands. Must be able to explain audit results and influence other's understanding of audit observations in a culturally sensitive, tactful, and professional manner. Experience with International Relations, preferred. Experience with distributors and importers, preferred. Extra Awesome:Bachelor’s degree in engineering, preferably Mechanical Engineering or the equivalent education and applicable work experience. ISO lead auditor certification or equivalent, preferred. 10 years of related experience in the field including:Experience leading and partnering with a quality assurance team through the various stages of development, from small startup organization to large organization. Experience supporting US and international regulatory authorities or notified bodies. Experience conducting internal audits. WHY YOU’LL LOVE WORKING HERE:At Tandem, we believe joy fuels excellence. That's why we've built a workplace that celebrates your achievements and supports your well-being. Our team thrives on pushing boundaries and fostering growth, all while maintaining a spirit of fun and camaraderie. This is just one of the ways we stay awesome!BE YOU, WITH US!We embrace the value that every single one of us brings to the table. But sometimes we forget that when we don’t meet 100% of a job description’s criteria – maybe you’re feeling that way right now? We encourage you to apply anyway. Because we want you to be you, with us. Tandem is firmly committed to being an equal opportunity employer and does not discriminate on the basis of age, disability, sex, race, religion or belief, gender identity or expression, marriage/civil partnership, pregnancy/maternity, or sexual orientation. We are an inclusive organization, and we welcome applications from a wide range of candidates. Selection for roles will be based on individual merit alone. REFERRALS:We love a good referral! If you know someone who would be a great fit for this position, please share!Make a move that matters. Join Tandem Diabetes Care, where we're turning challenges into triumphs every day and where your talents will help shape a healthier, happier tomorrow.