Sr Design Assurance Quality Engineer II

2 hours ago

Gurugram, India Hollister Full time

 Summary: The Design Quality Assurance team is an integral part of developing and bringing to market innovative new products and technologies that make life more rewarding and dignified for people with challenging medical conditions. Responsibilities: Associates within the Design Assurance team Resource planning, allocation, and monitoring on projects and initiatives Mentor Design Assurance team on projects and ensure completion per timelines and expectations Support Design Assurance issues and escalate for resolution if required Be a core team member on SPRING or Continence projects as required Drive continuous improvement initiatives within the Design Assurance function Support the internal and external audit program Complete assigned Impact Assessments within the change control system Support periodic review of assigned design control procedures Support the development of the strategic direction for the Design Assurance function Complete gap assessments to new standards as required Ad hoc travel Essential Functions of the Role**: The successful candidate will engage with Global Team of Design Quality Assurance Engineers and cross functional partners as part of driving the new product development process.Work Experience Requirements8+ years of design assurance medical device experience is required.Relevant experience in the medical device industry Education Requirements Degree in Engineering/Science Discipline or Quality Engineering Qualification Specialized Skills/Technical Knowledge: Experience in Quality Systems and Design AssuranceWorking knowledge of ISO 13485 and FDA 21 CFR Regulations and BS EN ISO 14971Software: Knowledge and experience of Word, Excel, PowerPoint and MinitabKnowledge of statistical data analysisAn ability to work independently and as part of a team. The successful candidate will be able to organize their own work on a routine basis.Experience in working in cross-functional teams Mode - Hybrid Location - Gurugram

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