Manager Quality Assurance
Resume:
Alejandro D. Manunta
Amherst, NY *4226
adm.js.2011
@gmail
.com
Quality Assurance and Validation
Bilingual Regulatory and Quality Assurance Leader able to coordinate, mentor and coach multiple teams of engineers,
designers and inspectors across multiple languages, cultures and continents in a harmonized and synchronized fashion,
in order to achieve a common goal in the development of innovative products within a highly regulated environment.
Key Skills and Strengths
• Verification & Validation. Design of Experiments (DOE). Testing according to ISO, ASTM and other national and
international Standards. Certified ISO 13485 auditor.
• Creative and results driven professional with significant experience leading product compliance in an FDA regulated
company.
• Skilled communicator able to eliminate cultural barriers and adapt to business protocols within global environment.
Fluent in English and Spanish and proficient in Portuguese, French and Italian.
• Six Sigma Black Belt. Risk management conscious, developing FMEAs, Control plans. APQP.
Career Experience
2001 – December 2012
ACCUMED INNOVATIVE TECHNOLOGIES, INC. Buffalo, NY
Medical Device Manufacturer
• Strategic Business Unit Engineering and Sourcing Manager, 2011 December 2012
o Lead a product development group between our Buffalo headquarters and our plant in the Dominican Republic,
assuring compliance with ISO 13485 and that IQ OQ PQ was performed in all new equipment and production
lines.
o Ensured that Device Master Records (DMR) and Device History Records (DHR) were in accordance with CFR21
Section 820.181.
o Mentored process of Validation of new suppliers.
• Global Innovation Manager, 2010 2011
o Designed new V&V controls for incoming raw materials. Analyzed data through the use of Minitab. And regulated
issue of non conformance material reports (NCMRs).
o Follow up of vendor corrective actions (VCAR) and member of Material Review Board (MRB).
o Coordination of lab testing with government contractors, universities and independent labs to meet different
industry, government standards, as well as FDA and EPA requirements.
o Implemented Risk Management through the development of P FMEAs and D FMEAs.
o Keeper of regulatory processes (REACH, RoHS, CE, etc) and Intellectual Property.
• Product Development Manager, 2008 2010
o Coordinated submission of 510k to the FDA in different modalities. Including Pre IDE analysis.
o Wrote reports summarizing statistical product and equipment data.
Alejandro D. Manunta
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o Identified and procured laser CMM equipment with SPC software to increase efficiency and speed of Production
Part Approval Process (PPAP).
o Leadership of a cross functional Product Development team that haste d ideas to commercialization within an
ISO/lean compliance environment.
o Managed CAPA through a Root Cause Analysis approach.
Alejandro D. Manunta
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• New Product Development Manager, 2006 2008
o Developed the Advanced product quality planning (APQP) process for our company and led the team implementing
it.
o Mentored an intern in his Six Sigma project troubleshooting and validating our flame lamination process through
the creation of a DOE and Minitab analysis.
o Conducted supplier audits at overseas location according to standard ISO 9001.
• Senior Product Development Engineer, 2001 2006
o Member of problem solving team utilizing 5 Whys, Ishikawa and 8Ds techniques.
o Formal training in problem solving through TCIE.
o Operated, supervised and procured CAD/CAM equipment for automated cutting room.
2000 2001
BIG BEAR, INC. Buffalo, NY
Computerized embroidery
Production Manager
Supervised production, assured that quality goals and deadlines were met. Devised and implemented new methods to
make production more efficient.
1995 – 2000
TEKNIKA, Asunción, Paraguay
Freelance consulting
Consultant
Provided consulting services in the areas of pattern making, cutting room and computerized embroidery to multiple
fashion apparel companies across South America.
1990 1995
CRIDEN S/WEMASA S.A., Asunción, Paraguay
Industrial Equipment Supplier
• Hi Tech Dept. Manager, 1991 1995
o Developed Dept. in charge of CAD/CAM equipment for the Apparel industry.
• Technical Sales, 1990 1995
o Made presentations to industry leaders.
o Directed booth activities at national exhibit.
Education
Six Sigma Black Belt,
University at Buffalo, Buffalo, NY.
Certificate in Business,
Universidad Americana, Asuncion, Paraguay.
Post Graduate in Aerospace Technology (similar to American MS),
Universidad Tecnológica Nacional, Buenos Aires, Argentina.
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• Scholarship of Argentinean Air Force.
Title of Mechanical Engineer (similar to American BS/MS).
Universidad Nacional del Nordeste, Resistencia, Chaco, Argentina.
• Ministry of Finance Scholarship
• Assistant to the Computing Department.
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