Requirements: English
Company: Tandem Diabetes Care International
Region: Saint-Sulpice , Vaud
Tandem Diabetes Care Switzerland Srl, a subsidiary of Tandem Diabetes Care, Inc., is a MedTech start-up located in EPFLs Innovation Park in Lausanne, Switzerland. Tandem Diabetes Care, Inc., is a global insulin delivery and diabetes technology company based in San Diego, California. Together we are creating new possibilities for people living with diabetes, their loved ones, and their healthcare providers through a positively different experience.
INNOVATE EVERYDAY:
Tandem Diabetes Care Switzerland is developing Sigi, a next-generation insulin patch pump that will offer additional treatment options for people with diabetes. This pump is based on a patented microfluidics technology developed in-house during the past 10 years.
WHEN & WHERE YOULL WORK:
On-Site: This role is on-site five days a week at our Lausanne, Switzerland office due to the nature of the work involved.
A 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. 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.
- Oversees market authorization requirements for product distribution (OUS).
- Interprets regulations/standards and develops compliance strategies.
- Develops, implements, and maintains processes to ensure compliance with regulatory requirements.
- Recommends 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.
- Manages, leads and/or oversees 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.
- Partners with domestic and international marketing teams, and other departments as needed, to identify the requirements for qualification, management, and monitoring of suppliers.
- Partners with Legal, Regulatory, process owners and suppliers to create and revise Quality Agreements, as needed.
- Qualifies, manages, and monitors supplier performance per Tandem supplier management approved processes. Identifies gaps in current processes to develop, define, establish, and document new processes, as needed.
- Oversees suppliers, as needed, to ensure their performance is acceptable.
- Ensures CAPA/SCAR resolution without undue delay for suppliers, including timeliness of responses and action plans.
- Tracks internal matrix trends (complaints/NCR/Internal audit) and suggests process improvements based on observations or provides quality input to CAPA process.
- Analyzes supplier information and presents supplier metrics in appropriate meetings, including internal and supplier managed meetings.
- Develops, implements, and manages supplier audit tools, including performance evaluation methodology and metrics, as needed.
WHAT YOULL NEED:
- 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 work independently to identify potential quality issues and implement solutions.
- 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.
- Ability to assert own ideas and persuade others through effectively consolidating, evaluating, and presenting relevan