Current resume

1. Lisa M. A. Burdick
5 Wildwood Road, Holden, MA 01520 (508) 335-6865 lisaburdick1@gmail.com
OVERVIEW
Results-oriented Quality and Regulatory professional with extensive experience working in ISO 13485 / FDA
regulated environment. Areas of expertise include Quality documentation for CMO manufacturing processes, lot
release, environmental and bioburden monitoring, Medial Device sterilization and process re-engineering.
 Adept analysis skills for scrutinizing and evaluating systems,software,productoperation,proces s flows or projectgoals and
interpreting into practical documentation,procedures or processes.
 ISO 9001 and ISO 13485 quality systems experience,as well as familiaritywith FDA QSR and AS 9100.
 Develop and rolloutof ISO 14001 quality system.
 Value stream mapping for medical device Quality Systems and Contract Manufacturing Organization (CMO) production work
cells.
 Spirited,self-motivated,detail orientated and creative thinking individual who works well at all levels of an organization.
 Exceptional communication,negotiation,and problem solving skills with keen eye for detail.
 Significant experience working with international CMO’s.
 Outstanding abilityto manage cumbersome,data driven projects to successful completion or implementation.
 Strong understanding ofmedical device sterilization processing,including sterile load release and C ycle Specification
Agreement documentation management.
 Extensive experience with calibration gage managementsystems.
PROFESSIONAL EXPERIENCE
Valeritas, Shrewsbury, MA April 2013 – present
ISO 13485 and FDA certified company, developed a disposable needle free injector insulin pump for the treatment of
Type 2 diabetes.
Senior Quality Systems Specialist (Report to Vice President, Regulatory and Quality)
Lot Release
 Redefine DHR content, document and implement checklists and new management processes which lead to eliminating process steps and
reducing DHR creation and approvaltime by 75%.
 Responsible for all lot release data review and escalation prior to release for commercialdistribution, lot release reports, microbiological test
reports, w orkinstructions and management and coaching of CMO to manage expectations.
 Work w ith Commercial Distributors to eliminate product lot status definition confusion and prevent inadvertent release.
 Interview ed, hired and managed 3 Quality SystemSpecialists to assist w ith lot release and other quality functions.
Sterilization
 After workforce downsizing, inherited sterilization load release and subsequent sterilization CMO management.
 Review ed LAL Endotoxin testing process and was able to reduce costs by $37,880 annually.
 Create sterile load release checklists and w orkinstructions to make load release seamless and less resource specific.
 Assist in multiple sterilization revalidations, validations and new product protocols at U.S. and Chinese sterilizers.
 Wrote verification and protocolfor Sterile Load Contents w orksheet, which providesguidance on product allow ed in sterilization chamber.
Process Flow Documentation
 Created Process Flow Map of entire production process to prevent systemand documentation failures during production migration to
Chinese CMO’s. Process included: Sub-Assembly CMO’s, Sterilizer, Final Assembly CMO and Commercial Distribution provider.
 Developed Inspection and Work Flow tracker to allow for realtime capacity planning and X-Ray throughput of product – eventually
transferred toolto CMO for reporting.
Documentation, Calibration & Auditing
 Responsible for performing internalaudits, assist w ith ISO recertification and Tech File review audits.
 Wrote and initiated over 70 DCN’s for documentation revisions or improvements or new documentation
 Initiated decommissioning of unused clean rooms resulting in annual savings of over $36,000 on operating expenses and $15,000 on
recertification and gage calibrations.
 Provide Gap Analysis betw een QMS and CMO QMS to provide continual seamless production transition
 Realigned disjointed Calibration department – created, documented and released new process management documentation
 Manage 800 gages for manual gage tracking system.
CAPA, SCAR & NCMR’s
 Initiate and trackinternal CAPA’s or SCAR’s for Sterilizer, Final Assembly CMO and Commercial Distributors.
 Managed NCMR’s, test data reports, and performance testing for 145 lots under tight timelines. Provided daily status reports to Senior
Management team.
 Key member of 2 field event teams to prevent potentially compromised product frommoving through Supply Chain
 Participant in MRB meetings, create NCMR’s and corresponding Disposition Instructions as needed.

2. Lisa M. A. Burdick
5 Wildwood Road, Holden, MA 01520 (508) 335-6865 lisaburdick1@gmail.com
Karl Storz Endoscopy, Charlton, MA Sep 2012 – Apr 2013
ISO 9001, 13485, 14001 and FDA certified international family owned company, currently manufacture a host of
endoscopic equipment up to and including entire operating room systems.
Configuration Management Specialist /Contractor (Report to Materials Manager)
 Contract position thatwas initiallydeveloped to create 50,000 UBOM’s for 64 manuals,inserts and labels (MIL’s) in Material
Master of SAP. Recognized project scope was incomplete and redefined the scope to include 194 MIL’s.
 Created a verification process to confirm data approved by Regulatory for each MIL was accurately entered into SAP.
Found an error rate of 10% from previouslyentered items. Maintained a less than .05% accuracy rate for life of project.
 Cut down data entry time from 7 minutes per BOM entries to 35 seconds byutilizing shortcuts and working with internal IT
departmentto understand and utilize software.
 Developed a dashboard for projectstatus,uploaded to TeamSpace,and maintained dailyto provide real -time updates for
team members.
Parental leave from March2011 to September 2012.
Web Industries, Holliston, MA 01746 Mar 2009 – Mar 2011
ISO 9001,13485,14001, AS 9100 certified contract manufacturer offering complete range ofhigh-standard converting services,
including slitting,rewinding,spooling,traverse winding,coating,laminating,and printing.
Site Quality Leader (Report to Process Engineering and Quality Manager and Corporate Quality Systems Manager)
 Successful rolloutofISO 14001 Environmental standard bytaking initiative and learning the standard via online course,
developed documentation and training programs for companywide implementation,became Environmental Management
Representative and was lead auditor for certification auditwhich was passed with no nonconformance’s or major/minor
findings.
 Managed cross functional teams for CAPA resolutions for internal and external customers. Created an auditfor
effectiveness program for implemented CAPA solutions.
 Revamped existing In-process Auditprocess to yield more detailed,and by default, actionable results.
 Conceived a trial process to track the key components ofnew products and new customers for easier crossover for
production implementation and tracking time,labor,and costing. Documented and trained companywide users on process.
 Responsible for plantwide training on a variety of topics ranging from Quality regulations to safety requirements.
 Worked with internal MRP software designers to troubleshootand assistwith validations as required byISO 13485.
Columbia Tech, Worcester, MA Dec 2006 – Oct 2008
ISO 9001 and 13485 certified ContractManufacturing and Engineering Companyproducing commercial and medical devices.
Quality and Manufacturing Software Analyst (Reported to the Vice President of Quality)
March 2007 - October 2008
 Researched software requests from functional departments looking for off the shelfalternatives as well as making
recommendations for home grown alternatives.
 Developed the training curriculum as well as the training record tracking system utilizing knowledge ofMicrosoft Access.
Saved the company$2500.00 by building system in house instead ofpursuing commercial offthe shelfoptions.
 Designed a Non-conformance tracking database with contractprogrammer for daily use by multiple departments. Housed
over 50k lines of data. Allowed for real-time reporting ofmanufacturing non-conformances bycustomer and supplier issues.
Quantified total issues bywork cell or nonconformance type.
Systems Quality Improvement and Training Coordinator (Reported to Director of Quality and Vice President of Quality)
December 2006 - October 2008
 Managed quality improvements projects which were determined byfinancial payback and self-motivated vision for
improvements to broken processes. This included overhaul ofMRB process which lead to better interdepartmental
communications and reduction oflostrevenues by 15% due to materials being dispositioned in a timelymanner allowing for
vendor credits.
 Developed Training curriculum on over 80 topics;rewrote job descriptions and training plans by working with department
managers to capture key job functions.
 Conducted over 150 standup training classes.
 Revamped entire ECO/ECN process from a Quality perspective due to varied processes based on differentcustomers. The
end resultwas all customers followed same ECOprocess and were all billed accordingly,which created additional company
revenues.
 Rewrote all documentation for failing documentation Calibration department,researched software packages and found
suitable vendor.Trained 3 associates on managing software. Developed reporting tool in software to be able to determine
overdue gages instantly.

3. Lisa M. A. Burdick
5 Wildwood Road, Holden, MA 01520 (508) 335-6865 lisaburdick1@gmail.com
Application and Software Experience
 MS Office  Visio  MS Project
 SAP  Access  Adobe Acrobat
 QAD  SB Client
EDUCATION
University of Massachusetts at North Dartmouth, BFA – concentration in Textile Design and Handweaving
CONTINUINGEDUCATION
Valeritas – Lead Auditor Training 5/20/15
Omnex Systems – Changes to ISO 13485 4/30/15
Compliance Online Webinar – A Systematic Approach to Writing Effective SOP’s 1/23/15
Compliance Online Webinar – CurrentRegulatory Requirements for Sterile Products 12/5/14
Compliance Online Webinar – Understanding ISO13485 & Relation to FDA's QSR 10/10/14
Compliance Online Webinar – UDI Implementation 8/28/14
Nancy Singer Webinar - Dangerous Documents – Avoiding Landmines in your FDA Records and E-mails 1/24/14
Fitchburg State – Statistical Process Control 12/2013
Web Industries 13485 & 14001 Lead Auditor Training
Quality Web Based Training 14001 – Environmental ISO Standard - Requirements Ato Z