Sr Design Control Quality Engineer
vor 1 Woche
GROW WITH US:
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 the 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 over the past 6 years.
A DAY IN THE LIFE:
The Sr Design Control Quality Engineer will act as an experienced senior team member providing quality guidance and support for design control, product transfer to manufacturing, sustaining engineering, production and quality system activities to assure conformance to established specifications and risk reduction. The Sr Design Control Quality Engineer will act as a leading member of the team to optimize and continuously improve internal operations to meet department, business unit and company objectives. He/She will also provide expertise and guidance to ensure systems are in place across the organization that improves quality of our devices as well as our business operations.
Working from Tandem Diabetes Care Switzerland’s office onsite in Switzerland, you’ll have to:
- Serve as a Quality reference on product design/development and sustaining engineering project teams.
- Provide input and contribute content to design control traceability matrix.
- Ensure design outputs compliance to design requirements.
- Ensure consistency between design inputs and design outputs.
- Review and approve product and process changes/new designs to assure they are developed, verified, validated and documented in accordance with regulatory requirements.
- Develop, update and review all technical documentation (Design inputs/Outputs, Specifications, Design Review, etc.) within the established procedures for recording data.
- Prepare the necessary technical documentation to support a review of the relevant competent authorities in accordance with the applicable standards in force.
- Support the Quality System process related to Design Control and Change Control.
- Support updates to operating procedures, processes, product/specifications, risk management files, test methods, etc.
- Analyze and solve quality related problems with products and processes.
- Review and provide quality input to Complaint, FA, CAPA, NC investigations and execute corrective actions when applicable.
- Participate in Risk Analysis, Design Reviews, DOEs, V&V Testing, and reliability testing activities.
- Facilitate or participate in cross-functional or cross-divisional process improvement teams to drive operational quality excellence and cost savings initiatives.
- Review and analyze project and customer requirements and assist project teams in tailoring and using company procedures, methods, templates and tools.
- Collect lessons learned, review and evaluate processes and work products and recommend improvements as appropriate.
- Support and lead internal and external audits as scheduled.
- Confirm completion of required training plan before assuming job responsibilities.
- Ensure work is performed in compliance with company policies including Privacy/GDPR/HIPAA and other regulatory, legal, and safety requirements.
- Other responsibilities as assigned.
YOU'RE AWESOME AT:
- Demonstrate highly proficient knowledge of Quality Engineering policies, principles and best practices.
- Proficient knowledge of quality standards: ISO 13485, 21CFR Part 820, ISO 14971 and other appropriate industry standards.
- Advanced knowledge and application of principles outlined in Good Documentation Practices (GDP) and Good Manufacturing Practices (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.
- Good understanding of mechanical drawings & specifications including geometric dimensioning and tolerances (GD&T).
- Able 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.
- Able to assert own ideas and persuade others through effectively consolidating, evaluating, and presenting relevant information.
- Skilled at creating a cooperative team environment.
- Able to objectively evaluate situations and make recommendations for changes in light of overall project demands.
- Adept at seeing change as an opportunity to improve business performance and campaigning for it when necessary.
- Ability to effectively use MS Office suite (Word, Excel, Outlook) and other applicable software packages.
- Fluency in English (written and spoken) required, fluency in French (spoken) strongly preferred.
YOU'LL NEED:
- Master’s degree in Engineering, preferably Mechanical Engineering, Biomedical Engineering or the equivalent education and applicable work experience.
- Certified Quality Engineer, Six Sigma Blackbelt, Quality Auditor, Reliability Engineer, or equivalent desired.
- 5 years’ experience working as a Quality Engineer in a medical device, manufacturing or a regulated industry.
- Experience in a GMP or ISO environment preferred.
BE YOU, WITH US
We are firmly committed to being an equal opportunity employer and maintaining a diverse and inclusive environment. We value and embrace that every single one of us brings value 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.
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