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Hollister Incorporated
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Sr Design Assurance Quality Engineer II

Sr Design Assurance Quality Engineer II

Hollister Incorporated

5 - 8 years

0 Lacs

Gurugram Haryana India

Posted:1 week ago| Platform:

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Skills Required

design planning monitoring support drive audit development engineering regulations word excel powerpoint minitab data analysis

Work Mode

On-site

Job Type

Full Time

Job Description

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 Requirements

5 to 8 years of design assurance medical device experience is required.
Relevant experience in the medical device industry

Education RequirementsDegree 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

Local Specifications (English And Local Language)

Fluency in English is requiredLocation - GurugramMode - Hybrid

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Sr Design Assurance Quality Engineer II