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Engineer
Infobahn Softworld
posted 3mon ago
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Flexible timing
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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"
Employment Type: Full Time, Permanent
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Flexible timing
Monday to Friday
No travel
Day Shift
Infobahn Softworld Benefits
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