Manager Document Control
Resume:
Cindy Lalowski
San Jose, Ca. *****
*************@*******.***
Document Management Professional
Document Control management or individual/team contributor experience and history of driving project results. Take on critical projects and complete them on time to drive positive changes. Reputation for being action oriented, driving timely decisions, being a team player. Strengths include:
• Successfully led Startups through ISO certification and conducted internal and external ISO audits.
• Implemented RoHS/WEEE with component engineering and an outside consultant.
• Manage New Product Introductions across multiple business units, suppliers and contract manufacturers.
• Provide support for FDA audits.
• Implementation of both Agile and Arena.
• Create and update department and cross functional SOP & WI's.
SKILLS
Operating Systems: Databases: ASK Manman and ASK Engineer, Expandable, JD Edwards and Oracle.
Software: MS Office (Word, Windows, Excel, Power Point, Visio, Outlook, SharePoint), Adobe Acrobat.
PLM: Arena, and Agile.
ISO 9000 and ISO 13485, FDA, 21CRF-Part 820, GMP, HIPAA, Clinical Trails
CPR & First Aid Certified
Lunera Lighting Inc.
Document Control Manager 8/11 - Present
• Supported NPI working with Engineering, Operations, Compliance and Marketing to create part numbers, BOMs, documentation and assist with product configuration.
• Worked on labeling project to ensure all products are correctly labeled with UL and product labels.
• Cleaned up Arena database (duplicate part numbers) added sourcing for all component items and established closed loop change process within the company.
• Wrote SOP’s and WI’s for Document Control.
Align Technology (Invisalign) Medical Device
Document Specialist 3/07 - 7/10
• Created and processed all types of changes in Arena (ECO, DCO, MCO, VAL) with exceptional attention to detail and turnaround time.
• Created a process to identify employees at multiple site locations so as not to pay Arena for customization.
• Provided Arena and SOP process training to several departments in the company.
• Worked with Marketing, Creative, Supply Chain and Purchasing to roll out unique marketing tools.
• Worked with various departments to resolve issues with suppliers and our manufacturing facility.
• Created and updated BOMs, product specifications and other documents for several products.
Netgear
SR. Engineering Change Analyst 8/06 - 3/07
• Supported the Business Product teams which included all change types in Agile for new products and changes to existing products.
• Performed quarterly Agile training for the main campus employees.
• Led team in the initiation of the Document Control Manual.
• Interfaced with teams in the product configuration process to create BOMs and product releases.
Azul Systems
Document Control Manager 3/06 - 8/06
• Administered Arena with 45 users and conducted internal and supplier training. Active in Arena's next generation updates and coordinated external user group meetings.
• Completed all part entry, AML entry and data, all ECO's, Deviations, MCO's and product change notices.
• Provided input for new product introduction, in both Software and Hardware releases.
• Major team member in the coordination of RoHS AML changes working with an outside consultant and internal team members.
• Creation of BOMs, CCB chair person, found second sources for components and managed project releases with cross functional team members.
Cindy Lalowski 408-***-**** *************@*******.*** Page2
Topspin Communications/Acquired by Cisco May 2005
Document Control Manager 1/04 - 3/06
• Administered Arena with 106 users, and provided training to internal and external users.
• Completed all part entry, AML entry and data, BOMs, all ECO's, Deviations, Stop and Resume Ship notices.
• Conducted CCB meetings, PCN meetings and sent customer notifications.
• Provided input for new product introduction, for Software and Hardware releases.
• Major team member in the coordination of RoHS AML changes with engineering and purchasing.
• Worked with engineering team on Topspin to Cisco part number conversions.
Neoteris & Echelon (Contract Positions)
Document Control Manager/Agile Administrator 5/03 - 12/03
• Set up Agile, served as business analyst with Neoteris and Agile to complete project "Agile Implementation".
• Completed data entry, wrote procedures, created ECO's and chaired CCB.
• Administered Agile and trained employees at Neoteris.
• ECO Analyst, component review, BOM creation, Agile Administration at Echelon.
Tahoe Networks
Document Control Manager/Agile Administrator 7/01 - 6/03
• Using Agile, set up the part numbering system, AML requirements, and the change process.
• Processed all changes and chaired CCB as needed.
• Administered Agile with a 10 license and multi user/location base. Interfaced with Agile and IT to implement Agile.
• Wrote procedures meeting requirements for ISO9000 for Document Control.
• Created BOMs, coordinated product review and releases.
Calient Networks Inc.
Document Control Manager/Agile Administrator 2/00 - 6/01
• Established a part numbering system, AML requirements, and the change process.
• Assisted engineers by researching component databases on the internet to obtain data sheets as well as additional sources for existing components.
• Coordinated reviewed and released new products.
• Using Agile, processed ECOs, MCOs, Deviations, and chaired CCB as needed.
• Assigned part numbers, created/updated BOMs, maintained files in Agile as well as on a server.
• Administered Agile with a 60 license and multi user/location base. Set up new users, set up permissions, monitored Agile E-hub, and created company specific information on user defined pages in Agile.
• Set up searches (similar to reports) to assist the users. Wrote and updated procedures and work instructions pertaining to ISO9000/TL9000.
TMT Inc.
Document Control Manager 8/97 - 2/00
• Completely revamped a paper system to a home grown on line system.
EDUCATION
AA, Massage Therapy, De Anza College, Cupertino, Ca.
Certificate, Supervision & Management, Mission College, Santa Clara, Ca.
Certificate, Network Management (Several classes in Project Management), UC Santa Cruz Extension
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