The Design Assurance Engineer is responsible for QA Design activities for new product implementation, transfer of manufacturing, and other QA related projects as needed. This position is part of the Quality Department located in Grens in Switzerland (VD) and will be an on-site role.
What You Will Do
* Provide quality support and coordinate activities for collaboration programs with third parties and new product introductions (NPIs) and transfer of manufacturing projects.
* Create detailed, comprehensive, and well-structured change control strategy and records.
* Review requirements, specifications, and technical design documents to provide timely and meaningful feedback.
* Support the development, implementation, and continuous improvement of manufacturing processes and Quality Systems.
* Write, review, and approve all new site documentation ensuring compliance with QMS.
* Suggest solutions to identified site problems to ensure consistent project execution.
* Develop process improvement plans using a variety of Quality and Continuous Process Improvement tools, including but not limited to Process Mapping, Six Sigma, Lean Manufacturing, 5S, SPC, RCA, engineering studies, DOE, Gauge R&R, etc.
* Identify and report any EHS, Quality, or Compliance concerns and take immediate corrective action or escalation as required.
Who You Are
* Bachelor’s (or higher) degree in engineering or health sciences field or another related degree.
* Minimum 2-3 years’ experience in an ISO 9001, medical device, or pharmaceutical industry in an Engineering, Quality, Regulatory, or R&D related role.
* Demonstrated understanding of product development lifecycles, design change, document change control, process verification and validation methodologies, manufacturing/production process control methodologies, and servicing in a medical device environment.
* Ability to read and interpret professional journals, drawings, and technical procedures.
* Solid QA process knowledge with an emphasis on technical skills to ensure understanding of technical data and information; experience with device/instrument hardware and software and any experience in single use disposable kits is desirable.
* Proficient with Microsoft tools: Word, Excel, PowerPoint, Project, Minitab, and Visio.
* Excellent verbal, written, and presentation skills with the ability to communicate business issues clearly in English and French (spoken and written).
Travel, Motor Vehicle Record & Physical/Environment Requirements
* Ability to travel up to 10%.
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