Principal Quality Engineer

Tandem Diabetes Care Switzerland Sàrl; Saint-Sulpice; Hybrid; CHF 100’000 - 130’000; Vollzeit

Zusammenfassung

A leading MedTech start-up is seeking a Principal Quality Engineer to ensure compliance and quality management within the organization. The role involves developing quality plans, overseeing supplier audits, and ensuring adherence to international regulations. Join a highly motivated team in a cutting-edge environment at EPFL Innovation Park.

Leistungen

High-tech and innovative environment

Excellent working conditions

Autonomy in work

Opportunities for career growth

Qualifikationen

• 10 years of related experience in quality engineering.
• Proficient understanding of ISO and regulatory requirements.
• Experience leading quality assurance teams.

Aufgaben

• Ensure compliance with international regulatory requirements.
• Oversee supplier audits and quality management.
• Develop and implement quality processes.

Kenntnisse

Quality engineering knowledge

Problem-solving methodologies

Communication

Team leadership

Supplier performance evaluation

Ausbildung

Bachelor’s degree in engineering

Jobbeschreibung

Tandem Diabetes Care Switzerland Sàrl, a subsidiary of Tandem Diabetes Care, Inc., is a MedTech start-up located in EPFL’s 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. You can find out more about Sigi here .

WHEN & WHERE YOU’LL WORK :

Hybrid : This role will be a mix of in-office work and remote work.

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. 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.

Working as Principal Quality Engineer, you’ll….

• Be responsible for compliance in line with international, country-specific, and regulatory requirements, such as EU MDR, MDSAP, FDA, ISO, 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.
• Be 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.

WHAT YOU’LL NEED :

• Demonstrated depth and breadth knowledge of quality engineering and quality systems.
• Proficient knowledge of quality standards : ISO, 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 relevant information.
• 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.
• Skilled at effectively leading a cooperative team effort and organizing resources to achieve team goals. Able to make and prioritize process and resource decisions based on overall team needs.
• Ability to objectively evaluate situations and make recommendations for changes considering overall project demands.

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.

WHAT’S IN IT FOR YOU?

In addition to innovative technology, we have a culture that fosters the idea that the happiest people are the most productive people. Not only do we hire forward-thinking achievers to join our workforce, but we reward, develop, and retain them too. We offer :

• A high-tech and innovative environment in MedTech
• Excellent working conditions, autonomy, and being part of a motivated and highly qualified team
• Interesting and stimulating work in an innovative field with high potential
• Pleasant environment within the EPFL Innovation Park, with possibility to benefit from the campus infrastructure

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!

SPONSORSHIP :

Applicants must be authorized to work for any employer in Switzerland. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

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.