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JOEL	
  RAMOS	
  
151	
  Pittman	
  Ct.	
  Stephens	
  City,	
  VA	
  22655	
  |	
  540-­‐931-­‐4191	
  |	
  510-­‐701-­‐8599	
  |	
  joel.ramos2@upr.edu	
  	
  
CAREER	
  PROFILE	
  
Experienced	
   engineering	
   hands-­‐on	
   professional	
   with	
   track	
   record	
   in	
   fostering	
   business	
   relationships	
   through	
   strong	
  
communication	
  skills.	
  Ability	
  to	
  develop	
  ideas	
  and	
  implement	
  feasible	
  timeliness,	
  effectively	
  leading	
  teams	
  toward	
  product	
  
quality,	
   equipment/processes	
   validations	
   and	
   risk	
   mitigation.	
   Innovative	
   business	
   development	
   professional	
   with	
   keen	
  
ability	
  in	
  utilizing	
  previous	
  experience	
  and	
  adaptability	
  skills	
  to	
  improve	
  organizational	
  growth	
  through	
  attention	
  to	
  detail,	
  
exceptional	
   customer	
   service	
   and	
   unending	
   commitment.	
   Strategic	
   leader	
   and	
   team	
   member	
   proven	
   in	
   supporting	
   all	
  
phases	
  of	
  product	
  manufacturing,	
  while	
  ensuring	
  implementation	
  of	
  continuous	
  improvement.	
  Seeking	
  engineering	
  role	
  to	
  
apply	
  strong	
  technical	
  knowledge,	
  project	
  management	
  and	
  leadership	
  skills	
  to	
  growth	
  of	
  top	
  tier	
  company.	
  
	
   	
   	
  
AREAS	
  OF	
  STRENGTH	
  AND	
  EXPERTISE	
  
• Customer	
  Satisfaction	
  
• Leadership	
  
• Bilingual	
  Spanish	
  &	
  English	
  
• Conflict	
  Resolution	
  
• Process	
  Implementation	
  &	
  Improvement	
  
• Root	
  Cause	
  &	
  Risk	
  Mitigation	
  Analysis	
  
• MS	
  Office	
  Suite	
  &	
  Report	
  Generation	
  
• Business	
  &	
  Relationship	
  Development	
  
• Lean	
  Manufacturing	
  Concepts	
  
• Team	
  &	
  Project	
  Management	
  
• ISO	
  13485	
  &	
  Federal	
  Regulations	
  
• Strategic	
  Planning	
  &	
  Analysis	
  
• Validation	
  Engineering	
   • Manufacturing	
  &	
  Quality	
  Engineering	
   • Data	
  Collection	
  &	
  Analysis	
  
	
  
WORK	
  EXPERIENCE	
  
Baxter	
  Healthcare,	
  Bioscience	
  Division	
  –	
  Hayward,	
  CA	
   2014	
  to	
  2015	
  
Quality	
  Engineer	
  –	
  Design	
  Control/Design	
  Assurance	
  and	
  Validations	
  Department	
  
Contracted	
  with	
  Baxter	
  Healthcare,	
  a	
  medical	
  device	
  and	
  technology	
  company,	
  to	
  assist	
  and	
  develop	
  fundamentals	
  that	
  
support	
  improvements	
  to	
  the	
  Quality	
  and	
  Risk	
  Management	
  Systems.	
  
Key	
  Accomplishments:	
  
• Successfully	
  closed	
  out	
  third-­‐party	
  and	
  customer	
  audits	
  findings,	
  creating	
  reports	
  and	
  determining	
  proper	
  corrective	
  
and	
  preventive	
  actions.	
  
• Performed	
   packaging	
   and	
   shipping	
   validations	
   to	
   final	
   product	
   configurations	
   in	
   compliance	
   with	
   ASTM,	
   ISO	
   and	
  
ISTA	
  standards	
  in	
  order	
  to	
  ensure	
  and	
  maintain	
  product	
  quality	
  through	
  the	
  entire	
  manufacturing	
  cycle.	
  
• Pioneered	
  remediation	
  project	
  to	
  Device	
  Master	
  Records	
  (DMRs)	
  and	
  Design	
  History	
  Files	
  (DHFs)	
  in	
  order	
  to	
  comply	
  
with	
  federal	
  regulatory	
  requirements.	
  
• Completed	
   customer	
   complaints	
   investigations,	
   ensuring	
   corrective	
   actions,	
   if	
   applicable,	
   were	
   implemented	
   and	
  
communicated	
  effectively.	
  
• Improved	
  the	
  ease	
  of	
  use	
  of	
  Device	
  Master	
  Records	
  and	
  FMEAs	
  in	
  order	
  to	
  ensure	
  and	
  maintain	
  the	
  reliability	
  of	
  the	
  
Quality	
  Management	
  System.	
  
• Worked	
  as	
  an	
  equal	
  member	
  of	
  a	
  nine-­‐person	
  cross-­‐functional	
  team,	
  providing	
  technical	
  direction	
  and	
  execution	
  on	
  
project	
  tasks,	
  to	
  introduce	
  commercial	
  products	
  into	
  several	
  countries’	
  markets.	
  Team	
  efforts	
  succeeded.	
  
	
  
Stryker,	
  Inc.	
  –	
  Guayama,	
  P.R.	
   2012	
  to	
  2014	
  
Validation	
  Engineer.	
  Manufacturing	
  &	
  Quality	
  Support	
  Engineer	
  
Contracted	
   with	
   Medisearch/Stryker,	
   Inc.,	
   a	
   medical	
   device	
   company,	
   in	
   Guayama,	
   Puerto	
   Rico,	
   to	
   design,	
   analyze,	
  
execute	
  and	
  develop	
  project	
  plans,	
  cost	
  analysis	
  and	
  technical	
  reports	
  for	
  complex	
  projects	
  including	
  CAPA,	
  product	
  
development	
   and	
   computer/equipment/process	
   validations.	
   Utilized	
   engineering	
   expert	
   knowledge	
   to	
   support	
   daily	
  
operations	
   and	
   prepare	
   manufacturing	
   and	
   quality	
   assurance	
   SOPs	
   in	
   order	
   to	
   increase	
   company	
   cost	
   savings	
   and	
  
enhance	
  product	
  quality.	
  Delivered	
  status	
  report	
  presentations	
  to	
  key	
  managers	
  to	
  ensure	
  continued	
  functionality.	
  
Key	
  Accomplishments:	
  
• Re-­‐qualified	
  manufacturing	
  clean	
  room	
  achieving	
  environmental	
  compliance	
  with	
  ISO	
  14644	
  Standards	
  and	
  internal	
  
protocols	
  in	
  order	
  to	
  ensure	
  the	
  continuation	
  of	
  operations.	
  
• Developed	
  new	
  equipment	
  tooling	
  for	
  the	
  manufacturing	
  of	
  fluid	
  warmer	
  products	
  in	
  order	
  to	
  reduce	
  scrap	
  costs	
  and	
  
non-­‐conforming	
  products	
  increasing	
  product	
  quality,	
  performance,	
  process	
  efficiency	
  and	
  profitability.	
  
• Successfully	
   completed	
   CAPA	
   investigations	
   and	
   process/product	
   non-­‐conformance	
   reports,	
   mentoring	
   and	
  
coordinating	
  with	
  the	
  Engineering,	
  Quality,	
  Manufacturing	
  and	
  Purchasing	
  Departments	
  to	
  ensure	
  all	
  organizational	
  
goals	
  were	
  met.	
  	
  
• Implemented	
  risk	
  mitigation	
  strategies,	
  leading	
  and	
  developing	
  risk	
  assessments,	
  FMEAs	
  and	
  process	
  flow	
  charts	
  to	
  
illustrate	
  process	
  improvements	
  for	
  cost	
  savings.	
  
• Written	
  and	
  executed	
  IQ,	
  OQ	
  and	
  PQ	
  protocols	
  and	
  reports	
  for	
  computer,	
  process	
  and	
  equipment	
  validations	
  in	
  order	
  
to	
  establish	
  documentary	
  evidence	
  that	
  demonstrates	
  its	
  compliance	
  with	
  all	
  stages.
	
  	
  
EDUCATION	
  AND	
  TRAINING	
  
Bachelor	
  of	
  Science,	
  Mechanical	
  Engineering,	
  University	
  of	
  Puerto	
  Rico—Mayagüez	
  Campus,	
  2012	
  
Project	
  Management	
  Certification,	
  Mechanical	
  Engineering	
  Dept.,	
  University	
  of	
  Puerto	
  Rico—Mayagüez	
  Campus,	
  2012	
  
Lean	
  Manufacturing	
  Concepts	
  Certification,	
  Sigma	
  Service	
  Solutions	
  –	
  Caguas,	
  Puerto	
  Rico,	
  2013	
  
Additional	
  training:	
  Medical Devices Regulations 21 CFR Part 820, GAMP5,	
  SOPs	
  and	
  Experiment	
  Design	
  &	
  Statistics	
  

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Joel Ramos Resume

  • 1. JOEL  RAMOS   151  Pittman  Ct.  Stephens  City,  VA  22655  |  540-­‐931-­‐4191  |  510-­‐701-­‐8599  |  joel.ramos2@upr.edu     CAREER  PROFILE   Experienced   engineering   hands-­‐on   professional   with   track   record   in   fostering   business   relationships   through   strong   communication  skills.  Ability  to  develop  ideas  and  implement  feasible  timeliness,  effectively  leading  teams  toward  product   quality,   equipment/processes   validations   and   risk   mitigation.   Innovative   business   development   professional   with   keen   ability  in  utilizing  previous  experience  and  adaptability  skills  to  improve  organizational  growth  through  attention  to  detail,   exceptional   customer   service   and   unending   commitment.   Strategic   leader   and   team   member   proven   in   supporting   all   phases  of  product  manufacturing,  while  ensuring  implementation  of  continuous  improvement.  Seeking  engineering  role  to   apply  strong  technical  knowledge,  project  management  and  leadership  skills  to  growth  of  top  tier  company.         AREAS  OF  STRENGTH  AND  EXPERTISE   • Customer  Satisfaction   • Leadership   • Bilingual  Spanish  &  English   • Conflict  Resolution   • Process  Implementation  &  Improvement   • Root  Cause  &  Risk  Mitigation  Analysis   • MS  Office  Suite  &  Report  Generation   • Business  &  Relationship  Development   • Lean  Manufacturing  Concepts   • Team  &  Project  Management   • ISO  13485  &  Federal  Regulations   • Strategic  Planning  &  Analysis   • Validation  Engineering   • Manufacturing  &  Quality  Engineering   • Data  Collection  &  Analysis     WORK  EXPERIENCE   Baxter  Healthcare,  Bioscience  Division  –  Hayward,  CA   2014  to  2015   Quality  Engineer  –  Design  Control/Design  Assurance  and  Validations  Department   Contracted  with  Baxter  Healthcare,  a  medical  device  and  technology  company,  to  assist  and  develop  fundamentals  that   support  improvements  to  the  Quality  and  Risk  Management  Systems.   Key  Accomplishments:   • Successfully  closed  out  third-­‐party  and  customer  audits  findings,  creating  reports  and  determining  proper  corrective   and  preventive  actions.   • Performed   packaging   and   shipping   validations   to   final   product   configurations   in   compliance   with   ASTM,   ISO   and   ISTA  standards  in  order  to  ensure  and  maintain  product  quality  through  the  entire  manufacturing  cycle.   • Pioneered  remediation  project  to  Device  Master  Records  (DMRs)  and  Design  History  Files  (DHFs)  in  order  to  comply   with  federal  regulatory  requirements.   • Completed   customer   complaints   investigations,   ensuring   corrective   actions,   if   applicable,   were   implemented   and   communicated  effectively.   • Improved  the  ease  of  use  of  Device  Master  Records  and  FMEAs  in  order  to  ensure  and  maintain  the  reliability  of  the   Quality  Management  System.   • Worked  as  an  equal  member  of  a  nine-­‐person  cross-­‐functional  team,  providing  technical  direction  and  execution  on   project  tasks,  to  introduce  commercial  products  into  several  countries’  markets.  Team  efforts  succeeded.     Stryker,  Inc.  –  Guayama,  P.R.   2012  to  2014   Validation  Engineer.  Manufacturing  &  Quality  Support  Engineer   Contracted   with   Medisearch/Stryker,   Inc.,   a   medical   device   company,   in   Guayama,   Puerto   Rico,   to   design,   analyze,   execute  and  develop  project  plans,  cost  analysis  and  technical  reports  for  complex  projects  including  CAPA,  product   development   and   computer/equipment/process   validations.   Utilized   engineering   expert   knowledge   to   support   daily   operations   and   prepare   manufacturing   and   quality   assurance   SOPs   in   order   to   increase   company   cost   savings   and   enhance  product  quality.  Delivered  status  report  presentations  to  key  managers  to  ensure  continued  functionality.   Key  Accomplishments:   • Re-­‐qualified  manufacturing  clean  room  achieving  environmental  compliance  with  ISO  14644  Standards  and  internal   protocols  in  order  to  ensure  the  continuation  of  operations.   • Developed  new  equipment  tooling  for  the  manufacturing  of  fluid  warmer  products  in  order  to  reduce  scrap  costs  and   non-­‐conforming  products  increasing  product  quality,  performance,  process  efficiency  and  profitability.   • Successfully   completed   CAPA   investigations   and   process/product   non-­‐conformance   reports,   mentoring   and   coordinating  with  the  Engineering,  Quality,  Manufacturing  and  Purchasing  Departments  to  ensure  all  organizational   goals  were  met.     • Implemented  risk  mitigation  strategies,  leading  and  developing  risk  assessments,  FMEAs  and  process  flow  charts  to   illustrate  process  improvements  for  cost  savings.   • Written  and  executed  IQ,  OQ  and  PQ  protocols  and  reports  for  computer,  process  and  equipment  validations  in  order   to  establish  documentary  evidence  that  demonstrates  its  compliance  with  all  stages.     EDUCATION  AND  TRAINING   Bachelor  of  Science,  Mechanical  Engineering,  University  of  Puerto  Rico—Mayagüez  Campus,  2012   Project  Management  Certification,  Mechanical  Engineering  Dept.,  University  of  Puerto  Rico—Mayagüez  Campus,  2012   Lean  Manufacturing  Concepts  Certification,  Sigma  Service  Solutions  –  Caguas,  Puerto  Rico,  2013   Additional  training:  Medical Devices Regulations 21 CFR Part 820, GAMP5,  SOPs  and  Experiment  Design  &  Statistics