Cindy Lutz

Cindy Lutz Email and Phone Number

Sr. Quality Management Systems Manager at Smith & Nephew @ Smith+Nephew
Cindy Lutz's Location
Mars, Pennsylvania, United States, United States
Cindy Lutz's Contact Details

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About Cindy Lutz

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Cindy Lutz's Current Company Details
Smith+Nephew

Smith+Nephew

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Sr. Quality Management Systems Manager at Smith & Nephew
Cindy Lutz Work Experience Details
  • Smith+Nephew
    Sr. Quality Systems Manager
    Smith+Nephew Apr 2023 - Present
    Watford, Hertfordshire, Gb
  • Smith+Nephew
    Quality Systems Manager
    Smith+Nephew May 2019 - Apr 2023
    Watford, Hertfordshire, Gb
  • Smith+Nephew
    Sr. Document Control Specialist
    Smith+Nephew Jan 2016 - May 2019
    Watford, Hertfordshire, Gb
  • Bluebelt Technologies
    Sr. Document Control Specialist
    Bluebelt Technologies Nov 2012 - Dec 2015
  • Clearcount Medical Solutions Inc.
    Document Control & Purchasing Specialist
    Clearcount Medical Solutions Inc. Jan 2009 - Aug 2012
    Pittsburgh, Pa, Us
    Responsible for the implementation and continuous improvement of the Purchasing, Receiving, Document Control and Training Procedures, Work Instructions and Forms.Full responsibility for the implementation and maintenance of the Document Control system, including; Design History Files, Change Control, Document Control, and Library of Standards.Performed purchasing duties including quoting, buying and expediting orders for Engineering and Production. Worked closely with suppliers and ClearCount accounting to resolve invoice issues. Responsible for inventory management of ClearCount consigned material at Contract Manufacturers.Performed receiving duties according to documented procedures. Goods received included items for Engineering, R&D, and Service which required low level incoming inspection.Interfaced regularly with upper management, Engineering, R&D, Service and Office staff in support of Document Control, Training and Purchasing processes. Created effective Document Control training presentations utilizing PowerPoint. Provided training sessions resulting in positive feedback on content and presentation.Key support person in the establishment of the Quality System. Responsible for editing and formatting Quality System Procedures, associated Forms, Work Instructions and Templates. Experienced in ISO 13485:2003 and 21 CFR Part 820 - QSR regulations. Trained as an Internal Auditor for the Quality System.
  • Renal Solutions, Inc.
    Document Control & Purchasing Specialist
    Renal Solutions, Inc. Aug 2001 - Jan 2009
    Performed purchasing duties; quoting, buying and expediting orders, during company start-up. Responsible for the implementation of the Purchasing System. Assisted in creating the Purchasing and Supplier Qualification procedures. Worked closely with suppliers and RSI accounting to resolve invoice issues. Key Documentation Control support for Quality System documentation, New Product Development and Marketing. Full responsibility for the implementation and maintenance of the Document Control system, including; Design History Files, Change Control, Document Control, and Library of Standards.Interface regularly with upper management, engineering and non-engineering personnel in support of Document Control processes. Created effective Document Control training presentations utilizing PowerPoint. Provided training sessions resulting in positive feedback on content and presentation. Ensure continuous improvement in the Document Control area by updating procedures and training.Meeting coordinator for the Change Control Board consisting of Sr. Management. Responsible for ensuring the change control packages are complete.Report weekly to upper management status of Implementation Plan tasks resulting from approved Product Change Notices. Created and maintain a detailed excel spreadsheet which automatically updates key areas for reporting with minimal data input. Work with task owners to obtain status for input into matrix. Maintain data on Engineering Change Packages for reporting to upper management. Final report contains, change package processing time, quantity of ECNs and Part Numbers processed, and quantity of changes per revision, program and type.Responsible for maintaining the Document Control database and ensuring the accuracy of documentation. Performed BOM analysis as it pertained to the completion of the documentation. Assisted in scheduling and performing Internal Quality Audits as required by the FDA and ISO.
  • Harris Corporation, Rf Communications Division
    Buyer/Planner
    Harris Corporation, Rf Communications Division Jul 1999 - Aug 2001
    Melbourne, Florida, Us
    Served as Senior Buyer for leading secure wireless communications provider to government agencies. Started as the MRO buyer and then moved into production purchasing.Responsible for setting and maintaining accurate material requirements in the QAD ERP system the PRC117F production line.Administered RFQ’s, analyzed bids and expedited orders according to the daily requirements of the ERP.Worked with an international supplier to get key parts tooled and casted to meet Harris objectives on new product line. Worked with a local supplier to provide injection molded prototype parts while international supplier started up.Team member involved in resourcing headsets used on a majority of Harris radios resulting in large savings and faster turnaround.Purchasing support to specialized internal production department which filled custom orders not handled by regular product line. Responsible for fast turnaround of OEM and custom components to meet special orders.Chosen to work on a team of 3 people to review and streamline the purchasing procedures for the newly implemented purchasing contract system, QAD.Volunteered to be the training coordinator for the purchasing department. Responsible for organizing in plant training sessions and tracking attendance.
  • Valeo
    Sr. Buyer
    Valeo 1997 - 1999
    Paris, Île-De-France, Fr
    Formerly ITT AutomotiveResponsible for maintaining accurate material requirements in the SAP ERP system for spare parts used on production machinery. A line down situation was very costly to Valeo.Administered RFQs and analyzed bids for the procurement of print tooling, gauges and fixtures totaling 8 million dollars annually.Met performance objectives set according to corporate objectives in the following 4 areas: Minority dollars spent, Savings, Supplier Surveys and Supplier Rationalization. Managed integrated supplier programs to supply the plant with industrial supplies, forms, office supplies, copiers and faxes.Initiated a remanufactured laser toner cartridge program for the entire plant to utilize, resulting in twelve thousand dollars savings per year.
  • Wellport, Inc
    Document Control & Purchasing Specialist
    Wellport, Inc 1992 - 1997
    Performed Document Control, Purchasing and Production Planning functions for medical device contract manufacturer. Tracked open purchase orders and expedited shipments to meet production needs. Controlled over one thousand paper documents satisfying Good Manufacturing Practices (GMP) requirements.

Cindy Lutz Skills

Quality System Medical Devices Iso 13485 Supply Chain Management Product Development Process Improvement Fda Quality Management Cross Functional Team Leadership Continuous Improvement Iso Procurement Manufacturing Supply Management Supplier Evaluation Materials Management Business Process Improvement Material Requirements Planning Mrp Strategic Planning Esourcing Quality Assurance Electronics

Cindy Lutz Education Details

  • State University Of New York At Oswego
    State University Of New York At Oswego
    General

Frequently Asked Questions about Cindy Lutz

What company does Cindy Lutz work for?

Cindy Lutz works for Smith+nephew

What is Cindy Lutz's role at the current company?

Cindy Lutz's current role is Sr. Quality Management Systems Manager at Smith & Nephew.

What is Cindy Lutz's email address?

Cindy Lutz's email address is cl****@****hoo.com

What schools did Cindy Lutz attend?

Cindy Lutz attended State University Of New York At Oswego.

What skills is Cindy Lutz known for?

Cindy Lutz has skills like Quality System, Medical Devices, Iso 13485, Supply Chain Management, Product Development, Process Improvement, Fda, Quality Management, Cross Functional Team Leadership, Continuous Improvement, Iso, Procurement.

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