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Hollister Global Business Services India Private L
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Sr Design Assurance Quality Engineer II

Sr Design Assurance Quality Engineer II

Hollister Global Business Services India Private L

5 - 8 years

6 - 9 Lacs

Gurgaon

Posted:1 week ago| Platform: GlassDoor logo

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Skills Required

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

Work Mode

On-site

Job Type

Part 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 Requirements

Degree in Engineering/Science Discipline or Quality Engineering Qualification
Specialized Skills/Technical Knowledge:

Experience in Quality Systems and Design Assurance

Working knowledge of ISO 13485 and FDA 21 CFR Regulations and BS EN ISO 14971

Software: Knowledge and experience of Word, Excel, PowerPoint and Minitab

Knowledge of statistical data analysis

An 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 required

Location - Gurugram

Mode - Hybrid

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Sr Design Assurance Quality Engineer II