Project Quality Assurance

David F. Morra

*** **** *****, *********, ** **540 862-***-****

******@*****.***

Summary: Devoted, eager, professional seeking to continue a career within the medical device

i ndustry. Skills, refined through a variety of experiences, include design controls (21 CRF

820), new product development, project management, r isk management, auditing, cGMP,

CAPA, and NCMR .

Experience

Integra LifeSciences, Plainsboro, NJ: Leadership Development Program Associate; June 2011

– Present

• Project Management Rotation (March 2012 – March 2013, May 2013 – Present)

o Responsible for ensuring completion of all project activities from conception to

commercialization including but not limited to development of user needs, development

of concepts, verification, design and process validation, t ransfer of design, Good

M anufacturing Practices (cGMP), r isk management, and commercialization of global

market-leading medical devices

Drove team to decision to reduce inspection cost of product by $120,000 over life-

cycle of product

Devised launch strategy for partial launch, increasing revenue generation by

$50,000

o Authored several key documents including but not limited to design and development

p lans, verification and validation plans, t raceability matrices, verification protocols and

reports, validation reports, clinical evidence reports, IFUs, and notes to file contained in

design history files

o Integration and remediation of acquired company Design History Files (DHFs)

Audited DHFs to ensure compliance to corporate, FDA (21 CFR 820), and ISO

regulations and guidances ( ISO 13485:2003, ISO14971:2007 etc.)

Developed and led DHF integration and remediation including generating action

p lans, time lines, and documentation necessary for completion for integration

o Generated and maintained budgets and t imelines in Microsoft Project for up to five

simultaneous projects in various phases of development

o Presented monthly updates to Senior Divisional Management on status of project

t imelines, budgets, and any potential r isks that may arise

o Ensured all project related activities are in accordance with local & corporate standard

operating procedures, as well as FDA (21 CFR 820) and ISO guidances, standards, and

regulations (ISO 13485:2003, ISO14971:2007 etc.)

• International Regulatory Affairs Rotation (March 2013 – May 2013)

o Generated core design dossiers for international submissions for Japan, China,

Korea, Mexico, and Brazil

o Gathered, organized, and evaluated documentation from Extremity

Reconstruction and Spine division for development of core design dossiers

• Quality Assurance Analyst Rotation (June 2011 – March 2012)

o FDA Audit and response

Completed and authored multiple Corrective and Preventative Actions (CAPA)

and action i tems for FDA audit and response

Generated, modified, implemented, and t rained manufacturing personnel on

several new and existing site SOPs

Identified, retained, and worked with several different consultants on multiple

t asks including t raining, review of open and closed nonconformance files, and

generated supplemental information for documentation

o Owner of Nonconformance Process ( NCMR), i ncluded working with multiple

departments in manufacturing facility to ensure proper investigation, documentation,

and disposition of nonconforming materials

o Performed corporate internal audit on Salt Lake City manufacturing site

o Generated several key documents to harmonize the artif icial skin family of products

i ncluding design specifications and process Failure Modes and Effects Analysis (pFMEA)

covering several manufacturing sites

o Generated control plan with private labeling group provided to customer

B. Braun, Allentown, PA Intern Regulatory Affairs; May 2010 –

August 2010

• Created and organized documents for drug and device submission (NDA, MDL, 510(k), IDE,

D I N) to FDA and Health Canada

• Identified, indexed, and organized documents for regulatory submissions from B. Braun’s

Carrollton and I rvine locations

• Aided in the preparation of new FDA Infusion Pump Ini tiative and future 510(k)

submissions

Lehigh University, Bethlehem, PA Integrated Product Development; January 2010 –

December 2010

•

• Cooperated with a group of 5 other students, representing different disciplines, to bring a

p roduct from development to placement in pharmacies

• Worked with OraSure Technologies to develop a new applicator for their H istofreezer®

Portable Cryosurgical System

Lehigh University, Bethlehem, PA Research Project Leader, Material Sci. & Eng. Dept.; May

2009 – May 2010

•

• Developed experiments with Professor Sabrina Jedlicka to test how mechanical properties

a ffect protein folding, created laboratory reports, and wrote papers for submit tal to

academic peer-reviewed journals

Lehigh University, Bethlehem, PA University Productions Comedy Director; April

2008 – August 2009

• Negotiated contracts with the comedians and comedians’ managers for weekly smaller

events and biannual larger events

• Coordinated and managed all support functions, including advertising, venue setup, and

r unning live shows on stage

Lehigh University, Bethlehem, PA Orientation Coordinator; October 2008 –

October 2009

•

• One of 6 selected as Coordinator out of the 60 Orientation Leaders from the previous year

• Att racted applicants, selected, t rained, led and managed the 62 new Orientation Leaders

• Worked with University administration to design and implement new student orientation

p rograms for first year students

Education

Lehigh University, Bethlehem PA

Bachelor of Science, December 2010 (Graduated in 3.5 Years)

• Major: Bioengineering

• M inor: Materials Science and Engineering

Personal

Interests include: Basketball, Golf, Volleyball, Travel, Skiing, PADI Certified SCUBA Diver,

S tand-up Comedy

Contact this candidate