Senior Design Control Quality Engineer
vor 3 Wochen
We are seeking a highly skilled Senior Design Control Quality Engineer to join our team at Tandem Diabetes Care Switzerland Sàrl. As a key member of our quality team, you will be responsible for ensuring the design and development of our medical devices meet the highest standards of quality and regulatory compliance.
Key Responsibilities- Provide quality guidance and support for design control, product transfer to manufacturing, sustaining engineering, production, and quality system activities.
- Act as a leading member of the team to optimize and continuously improve internal operations to meet department, business unit, and company objectives.
- Ensure systems are in place across the organization that improve the quality of our devices and business operations.
- Review and approve product and process changes/new designs to ensure they are developed, verified, validated, and documented in accordance with regulatory requirements.
- Develop, update, and review all technical documentation within established procedures for recording data in accordance with procedures.
- Prepare technical documentation to support reviews of relevant competent authorities in accordance with applicable standards.
- Support the Quality System process related to Design Control and Change Control.
- 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 activities such as 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.
- 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.
We offer a dynamic and inclusive work environment, competitive compensation, and opportunities for professional growth and development. If you are a motivated and experienced Quality Engineer looking for a new challenge, please submit your application.
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**Senior Design Control Quality Engineer**
vor 2 Monaten
Saint-Sulpice VD, Waadt, Schweiz Tandem Diabetes Care Switzerland Sàrl VollzeitAbout the RoleWe are seeking a highly skilled and experienced **Senior Design Control Quality Engineer** to join our team at Tandem Diabetes Care Switzerland Sàrl. As a key member of our quality assurance team, you will play a critical role in ensuring the development and delivery of high-quality medical devices that meet the highest regulatory...
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Senior Design Control Quality Engineer
vor 3 Wochen
Saint-Sulpice VD, Waadt, Schweiz Tandem Diabetes Care Switzerland Sàrl VollzeitAbout the RoleTandem Diabetes Care Switzerland Sàrl is seeking a highly skilled Senior Design Control Quality Engineer to join our team in Lausanne, Switzerland. As a key member of our quality team, you will be responsible for ensuring the design and development of our medical devices meet the highest standards of quality and regulatory compliance.Key...
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vor 4 Wochen
Saint-Sulpice VD, Waadt, Schweiz Tandem Diabetes Care Switzerland Sàrl VollzeitAbout the RoleTandem Diabetes Care Switzerland Sàrl is seeking a highly skilled Senior Design Control Quality Engineer to join our team. As a key member of our quality team, you will be responsible for ensuring the design and development of our medical devices meet the highest standards of quality and regulatory compliance.Key ResponsibilitiesProvide...
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Senior Design Control Quality Engineer
vor 3 Wochen
Saint-Sulpice VD, Waadt, Schweiz Tandem Diabetes Care Switzerland Sàrl VollzeitAbout the RoleWe are seeking a highly skilled Senior Design Control Quality Engineer to join our team at Tandem Diabetes Care Switzerland Sàrl. As a key member of our quality team, you will be responsible for ensuring the design and development of our medical devices meet the highest standards of quality and regulatory compliance.Key ResponsibilitiesProvide...
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vor 2 Monaten
Saint-Sulpice VD, Waadt, Schweiz Tandem Diabetes Care Switzerland Sàrl VollzeitAbout the RoleWe are seeking a highly skilled Sr Design Control Quality Engineer to join our team at Tandem Diabetes Care Switzerland Sàrl. As a key member of our quality team, you will be responsible for ensuring the design and development of our medical devices meet the highest standards of quality and regulatory compliance.Key ResponsibilitiesDesign...
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