Job Description

Job Title Configuration Designer



Configuration Designer:

You will be a part of Design/Document Control team, belongs to R&D department of MR Coils business. R&D is responsible for all engineering activities required to support our entire released product portfolio and install base as well as new product development. We focus on customer enhancement requests, complaints, reliability improvement, cost reduction, and compliance with new or updated regulations.

You will coordinate for complex design changes through the design change process and pioneer the use of new technical tools for improved communication of controlled documentation.

Your role:

• 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.

You\'re the right fit if:

• Advanced user of SAP, Windchill, or equivalent Product Data Management Systems.
• High attention to detail, key resource in bridging the communication between Engineering, Quality and Manufacturing.
• Thorough understanding of medical device regulations regarding design control.
• You are an Engineering graduate with atleast 8 years of experience with QMS Compliance within a worldwide Medical Device or Automotive, Food and Beverage, Cosmetics Industry, Sales.
• A seasoned, experienced professional with a full understanding of relevant standards and regulations.
• Minimum 5 years of experience using AutoCAD, Solidworks, or other CAD authoring tool.
• Professional written and oral communication skills across all levels of the organization.
• Accurate, superior planning, problem-solving and trouble-shooting skills with attention to detail and follow-through.
• Able to resolve issues proactively and independently in creative ways.
• Able to analytically assess impact to the Markets One QMS and the local organizations of changes applicable to the Market.
• Should be a quick learner and ready to adopt dynamic business needs.

About Philips
We are a health technology company. We built our entire company around the belief that every human matters, and we won\'t stop until everybody everywhere has access to the quality healthcare that we all deserve. Do the work of your life to help the lives of others.

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If you\xe2\x80\x99re interested in this role and have many, but not all, of the experiences needed, we encourage you to apply. You may still be the right candidate for this or other opportunities at Philips. Learn more about our commitment to diversity and inclusion .

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