Senior Design Control Quality Engineer

Vor 5 Tagen

SaintSulpice VD, Waadt, Schweiz Tandem Diabetes Care Switzerland Sàrl Vollzeit
About the Role

We 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 Responsibilities
  • Design Control: Provide 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.
  • Quality System Process: Support the Quality System process related to Design Control and Change Control, ensuring consistency between design inputs, design outputs, and regulatory requirements.
  • Technical Documentation: Develop, update, and review all technical documentation, including design inputs/outputs, specifications, design reviews, and risk management files, in accordance with established procedures.
  • Regulatory Compliance: Ensure design outputs comply with regulatory requirements, including ISO 13485, 21CFR Part 820, and other applicable industry standards.
  • Problem Solving: Analyze and solve quality-related problems with products and processes, using problem-solving methodologies such as why-why analysis, fault tree analysis, and cause-and-effect diagrams.
  • Team Collaboration: Facilitate or participate in cross-functional or cross-divisional process improvement teams to drive operational quality excellence and cost savings initiatives.
  • Training and Development: Confirm completion of required training plans before assuming job responsibilities and ensure work is performed in compliance with company policies, including Privacy/GDPR/HIPAA and other regulatory, legal, and safety requirements.
Requirements
  • Education: Master's degree in Engineering, preferably Mechanical Engineering, Biomedical Engineering, or the equivalent education and applicable work experience.
  • Experience: 5 years' experience working as a Quality Engineer in a medical device, manufacturing, or a regulated industry, with experience in a GMP or ISO environment preferred.
  • Certifications: Certified Quality Engineer, Six Sigma Blackbelt, Quality Auditor, Reliability Engineer, or equivalent desired.
About Us

Tandem Diabetes Care Switzerland Sàrl is a MedTech start-up located in EPFL's Innovation Park in Lausanne, Switzerland. We are a subsidiary of Tandem Diabetes Care, Inc., a global insulin delivery and diabetes technology company based in San Diego, California. We are committed to creating new possibilities for people living with diabetes, their loved ones, and healthcare providers through a positively different experience.

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