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Infobahn Softworld

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3.5

based on 33 Reviews

219 Infobahn Softworld Jobs

Engineer

Infobahn Softworld Inc.

3.5

based on 33 Reviews

2-4 years

Pune

1 vacancy

Engineer

Infobahn Softworld

posted 5mon ago

Job Role Insights

Flexible timing

Key skills for the job

SAP CO AutoCAD Auditing Change Management Product Design Compliance

+ 2 more

Job Description

2-4 Years of experience
Windchill, Engineering change management process
"Advance user of Windchill / SAP Drawing reading"
"Coordinating the archiving, revision control, and release of product design specifications through the Product Realization Process
Coordinating engineering change process from EC submission through to implementation on manufacturing floor
Creation of specification documentation including CAD drawings, test and tune procedures
Guide complicated design changes through various business functions to ensure smooth release.
Facilitate the use of business process tools for the maintenance of medical device DMRs (Device Master Records)
Managing the QMS transition of the Philips standardized processes and tools for the MR Coils business
Provide guidance on documentation structures and format to ensure compliance to procedures, relevant regulations, and standards
Assist and support the Change Control processes requests for new/revised controlled documents
Ensure there are periodic reviews of all documents to maintain consistency to customer requirements, enterprise and local procedures and changes or improvements to site processes
Develop and maintain quality related metric dashboards including but not limited to daily management, CAPAs, audit findings, issue reviews, and others
Define, monitor, track, and report on documentation metrics (e.g. documentation release rates, documentation rejection and adoption rates, etc.)
Work collaboratively with internal customers to refine and optimize analysis and reporting criteria as well as manage expectations around analysis delivery timelines and output capabilities
Reviewing approved documents for accurate format, signatures, dating and Good Documentation Practices (GDP)
Drive solutions to ensure internal customer related problems/issues are communicated and managed at first time right
Establish routine communication strategies for project tracking and prioritization"