57505BR

　　Title:

　　Design Quality Engineer

　　Job Description:

　　Quest Global is an organization at the forefront of innovation and one of the world’s fastest growing engineering services firms with deep domain knowledge and recognized expertise in the top OEMs across seven industries. We are a twenty-five-year-old company on a journey to becoming a centenary one, driven by aspiration, hunger and humility.

　　We are looking for humble geniuses, who believe that engineering has the potential to make the impossible, possible; innovators, who are not only inspired by technology and innovation, but also perpetually driven to design, develop, and test as a trusted partner for Fortune 500 customers.

　　As a team of remarkably diverse engineers, we recognize that what we are really engineering is a brighter future for us all. If you want to contribute to meaningful work and be part of an organization that truly believes when you win, we all win, and when you fail, we all learn, then we’re eager to hear from you.

　　The achievers and courageous challenge-crushers we seek, have the following characteristics and skills:

　　Job Description

　　In this role, you have the opportunity to:

　　As Quality Engineer (QE) within our Emergency Care is responsible to ensure products are designed and produced to meet requirements and expectations.

　　Participates in the change management process to assure the products continue to meet customer requirements. Participate with cross-functional team with other business and engineering disciplines.

　　Having good communication skill verbal , written to interact with global team

　　.

　　You are responsible for:

　　Ensures that appropriate quality requirements are defined that include all stages of the life cycle of the product and supports design Quality Plan design

　　Performs independent technical assessment on design changes &product quality

　　Can facilitate problem solving and root cause analysis

　　Frequently interacts with subordinate supervisors and functional peer groups. Interaction normally requires the ability to gain cooperation of others, conducting presentations of technical information concerning specific projects or schedules.

　　Independently produces and completes Quality Engineering Documents.

　　,May also provide other quality engineering support, including assisting organizational units in leading resolution of quality engineering deficiencies.

　　Follow processes and operational policies in selecting methods and techniques for obtaining solutions.

　　Ensure the compliance requirements are met during Design review , design verification & Design validation , Design transfer

　　To succeed in this role, you should have the following skills and experience:

　　Bachelor’s Engineering degree with 6+ years of related experience -Mechanical/ Electrical/ Electronic or Equivalent Engineering

　　Hands on experience in problem solving technique

　　Working knowledge of appropriate global regulations, requirements, and standards.

　　3+ years of related experience in medical device or regulated industries preferably

　　Have an understanding of Statistical Methods , Safety Risk Management (i.e ISO 14971) and Failure Modes and Effects Analysis (FMEA) / Fault Tree Analysis

　　Applied knowledge of appropriate global medical device or consumer product regulations, requirements, and standards (21 CFR Parts 820, ISO13485, ISO14971, MEDDEV, EU MDR, etc.)

　　Auto req ID:

　　57505BR

　　Job Type:

　　Full Time-Regular

　　Assignment Country:

　　India

　　Total Years of Exp:

　　5-8

　　Education Type:

　　B.E/B.Tech/BS-Mechanical Engineering

　　Assignment State:

　　Maharashtra

　　Assignment Location:

　　Pune

　　Experience Level:

　　Mid Level