lisa burdick resume 2016

Lisa M. A. Burdick5 Wildwood Road, Holden, MA 01520 (508) 335-6865 [email protected]

OVERVIEWResults-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, product operation, process flows or project goals and interpreting into practical documentation, procedures or processes.

ISO 9001 and ISO 13485 quality systems experience, as well as familiarity with FDA QSR and AS 9100. Develop and rollout of 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 ability to manage cumbersome, data driven projects to successful completion or implementation. Strong understanding of medical device sterilization processing, including sterile load release and Cycle Specification

Agreement documentation management. Extensive experience with calibration gage management systems.

PROFESSIONAL EXPERIENCEValeritas, 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 approval time by 75%. Responsible for all lot release data review and escalation prior to release for commercial distribution, lot release reports, microbiological test

reports, work instructions and management and coaching of CMO to manage expectations. Work with Commercial Distributors to eliminate product lot status definition confusion and prevent inadvertent release. Interviewed, hired and managed 3 Quality System Specialists to assist with lot release and other quality functions.

Sterilization After workforce downsizing, inherited sterilization load release and subsequent sterilization CMO management. Reviewed LAL Endotoxin testing process and was able to reduce costs by $37,880 annually. Create sterile load release checklists and work instructions 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 protocol for Sterile Load Contents worksheet, which provides guidance on product allowed in sterilization chamber.

Process Flow Documentation Created Process Flow Map of entire production process to prevent system and 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 real time capacity planning and X-Ray throughput of product – eventually transferred

tool to CMO for reporting.

Documentation, Calibration & Auditing Responsible for performing internal audits, assist with 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 between 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 track internal 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 from moving through Supply Chain Participant in MRB meetings, create NCMR’s and corresponding Disposition Instructions as needed.

Karl Storz Endoscopy, Charlton, MA Sep 2012 – Apr 2013

mailto:[email protected]


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 that was initially developed 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 previously entered 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 by utilizing shortcuts and working with internal IT

department to understand and utilize software. Developed a dashboard for project status, uploaded to TeamSpace, and maintained daily to provide real-time updates for

team members.

Parental leave from March 2011 to September 2012.

Web Industries, Holliston, MA 01746 Mar 2009 – Mar 2011ISO 9001, 13485, 14001, AS 9100 certified contract manufacturer offering complete range of high-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 rollout of ISO 14001 Environmental standard by taking 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 audit which was passed with no nonconformance’s or major/minor findings.

Managed cross functional teams for CAPA resolutions for internal and external customers. Created an audit for effectiveness program for implemented CAPA solutions.

Revamped existing In-process Audit process to yield more detailed, and by default, actionable results. Conceived a trial process to track the key components of new 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 plant wide training on a variety of topics ranging from Quality regulations to safety requirements. Worked with internal MRP software designers to troubleshoot and assist with validations as required by ISO 13485.

Columbia Tech, Worcester, MA Dec 2006 – Oct 2008ISO 9001 and 13485 certified Contract Manufacturing and Engineering Company producing 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 shelf alternatives as well as making recommendations for home grown alternatives.

Developed the training curriculum as well as the training record tracking system utilizing knowledge of Microsoft Access. Saved the company $2500.00 by building system in house instead of pursuing commercial off the shelf options.

Designed a Non-conformance tracking database with contract programmer for daily use by multiple departments. Housed over 50k lines of data. Allowed for real-time reporting of manufacturing non-conformances by customer and supplier issues. Quantified total issues by work 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 by financial payback and self-motivated vision for improvements to broken processes. This included overhaul of MRB process which lead to better interdepartmental communications and reduction of lost revenues by 15% due to materials being dispositioned in a timely manner 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 different customers. The

end result was all customers followed same ECO process 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.



Application and Software Experience MS Office Visio MS Project SAP Access Adobe Acrobat QAD SB Client

EDUCATIONUniversity of Massachusetts at North Dartmouth, BFA – concentration in Textile Design and Handweaving

CONTINUING EDUCATIONValeritas – Lead Auditor Training 5/20/15Omnex Systems – Changes to ISO 13485 4/30/15Compliance Online Webinar – A Systematic Approach to Writing Effective SOP’s 1/23/15Compliance Online Webinar – Current Regulatory Requirements for Sterile Products 12/5/14Compliance Online Webinar – Understanding ISO 13485 & Relation to FDA's QSR 10/10/14Compliance Online Webinar – UDI Implementation 8/28/14Nancy Singer Webinar - Dangerous Documents – Avoiding Landmines in your FDA Records and E-mails 1/24/14Fitchburg State – Statistical Process Control 12/2013Web Industries 13485 & 14001 Lead Auditor TrainingQuality Web Based Training 14001 – Environmental ISO Standard - Requirements A to Z
