Sr. Design Assurance Quality Engineer

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

Complete Performance Management and Development Plans with team members

Resource planning, allocation, and monitoring on projects and initiatives

Mentor Design Assurance team on projects and ensure completion per timelines and expectations

Lead on Design Assurance issues raised by team members and escalate for resolution if required

Be a core team member on SPRING or Continence Care 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

Manage training plans for the team

Complete gap assessments to new standards as required

Ad hoc travel

Essential Functions of the Role**:

The successful candidate will lead a Global Team of Design Quality Assurance Engineers and will engage with cross functional partners as part of driving the new product development process.

Work Experience Requirements

8+ years of overall experience is required

Relevant experience in the medical device industry or equivalent regulated 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 organise their own work on a routine basis and requires minimal supervision

Experience in working in cross-functional teams

Local Specifications (English and Local Language):

Fluency in English is required

Work Mode - Hybrid

Location - Gurgaon