Quality Assurance
Resume:
A asco, PR *****
5107
ab9dwq@r.postjobfree.com
Evelyn Martiz Rom n
Profile Highly motivated professional with over twenty years of
experience in the Quality Assurance and Regulatory Compliance
fields. Key strengths include planning, organization and
coordination of the activities related to the procurement and
acceptance of materials. Highly effective problem solving and
complex negotiation skills involving the timely completion of
all the processes related to quality/ technical issues
pertaining to supply quality assurance.
Experience
April 2013 - Present
HandCraft Linen Svc. Richmond, VA
Corporate Quality Manager
Responsible for the implementation ogf the Quality system in
one plant and the improvement of the current quality system in
the the other, developing quality manual, standards, SOP's for
Production and Quality, metrics and CAPA. hiring, training,
evaluating performance of 6 direct reports.
Aug 2008 - Sep 2012
Honeywell Aerospace Aguadilla, PR
Audit & Standard Work Analyst
Responsible for the excellence in the Global Customer Care
Service by ensuring the
Customers, Quality, and Regulatory requirements are met.
Provided direct support to the Customer Care Team by ensuring
regulatory compliance
to Internal / External policies and standards. Performed
contract review for completeness and compliance required
standards. Dual role in acting as Commercial and Government
compliance liaison. Worked directly with DCMA (Defense
Contract management Agency), Honeywell Directors, Managers,
and Supervisors in solving Customer Care Service Internal/
External quality and compliance issues. Reviewed quality
procedures for adequacy and updated or developed new ones as
required. Facilitated compliance trainings and measured
effectiveness by performing monthly assessment's or process
reviews. Developed Corrective Action Request/ Product
Deficiency Reports (CAR's) trending review tools and analyzed
data to detect unsatisfactory trends or weaknesses. Improved
the process cycle time in accordance to internal and external
standards and also performed monthly analysis to identify AERO
systemic issues. Provided support during internal/external
audits. Reorganized and improved the Administrative Self
Assessment Review process, developed metrics and
standardized the process. Prepared weekly and monthly reports
to be presented to management and directors.
Oct 2006 - Jul 2008 Becton Dickinson Caribe
LTD. Las Piedras, P.R.
Quality Facilitator
Responsible for the Quality Control Operations, Incoming
Inspection, and Product Release areas. Total Direct Reports -
16
Assessed the production and QC inspector's activities/
capabilities to ensure adherence to Standards and Quality
Systems Procedures. Implemented QC inspector's cross training
in order to increase flexibility, improve service, ensure
talent development, and reduce overtime. Assessed and
reorganized the Product Release process to ensure Finish Goods
continuous flow. Product release on time improved from 48% to
72%. Improved the Quality Notifications Reports (QNR's)
handling process in order to prevent overdue items. QNR
closure was improved from 45% to 90% within 30 days or less.
Provided direct support to QC inspectors during the inspection
and testing process an in the interpretation of blueprints,
engineering drawings, product specifications, technical
manuals sampling techniques and data analysis. Direct
participation and support during internal and external audits
(FDA, BSI, Corporate). Performed investigations to determined
corrective/ preventive actions and ensured these were
correctly implemented. Monitored effectiveness in order to
ensure regulatory compliance requirements were met. Negotiated
and coordinated the participation of the required resources in
the resolution of technical quality issues in order to ensure
timely completion of tasks. Developed and implemented quality
procedures in order to ensure i
I
mprove effectiveness of the Quality Systems. Along with the
engineering, manufacturing and materials teams performed the
investigations and documentation of the Quality Notifications
Reports in order to reach effective resolution of the quality
issues related to raw material, components and finished
products. Active participation during Process Validations.
Worked closely with the raw materials suppliers to reduce
non-conformances, recommend corrective and preventive measures
to avoid non conformances recurrence. Prepared weekly and
monthly reports to be presented to management and directors.
Jan 1997 - Oct 2006 Edwards Lifesciences
Corporation A asco, P.R.
Incoming Inspection Supervisor /Supplier Quality Lead Auditor
Responsible for the Receiving Inspection, Quality Bond,
Returned Goods, and Supplier Quality Management areas.
Accountable for the supplier quality audits and for auditing
the plant internal audit program, including Quality Management
Reviews, handled by the internal plant auditor. Total Direct
Reports - 10 (8 senior inspectors and 2 quality engineering
technicians).
Performed at least 8 supplier audits per year. Developed the
supplier audit annual schedule, led the audit team, prepared
audit reports, and conducted follow up on the appropriate
implementation and closure of corrective / preventive actions
as required. Provided direct support to senior inspectors
during the inspection and testing process an in the
interpretation of blueprints, engineering drawings, product
specifications and manuals. Implemented several incoming
inspection programs to reduce inspection lead time such as
Supplier Certification, Sampling Reduction Plan, Skip Lot
Sampling, and Inspection at the Source Program. Improved the
Raw Material release on time from 76% to 95%. Evaluated and
certified 10 suppliers within two years. Implemented the
Inspection at the Source program at 7 supplier's facilities.
Aid the engineering department in new supplier's qualification
with an economic impact of 100K in material cost reduction.
Maintained Raw Material, Returned Goods, Rejected Materials,
and Consignment Raw Material inventories areas exceeding 97%
accuracy. Active support during the implementation of the
electronic Supplier Performance Monitoring Program. Led the
Resident Supplier program development, training, and
implementation. Developed training matrix for suppliers and
performed trainings at their facilities. Ensured program
effectiveness by monitoring supplier performance. Participated
actively in internal and external audits (FDA, TUV and
Corporate). Escort of external auditors to areas of
responsibility. Implemented cross training in order to
increase flexibility, ensure talent development, and reduce
overtime. Developed training course for new recruits.
Provided guidance and training to Senior Inspectors of Edwards
Lifesciences parent company at Dominican Republic. Prepared
weekly and monthly reports to be presented to management and
directors.
May 1990 - Jan 1997 Baxter Cardio
Vascular Group A asco, P.R.
Customer Affairs Specialist
Responsible for the transfer and implementation of the
Customer Affairs Operations to the Puerto Rico facilities.
Total Direct Report - 1 (Customer Affairs Clerk)
Coordinated the return, disposition, and rework of Customer's
Returned Goods. Maintained 100% accurate inventories of the
Returned Goods, Rejected Material, and Expired Products.
Maintained continual communication with Customer Service and
Customer Affairs
personnel of Baxter Cardio Vascular parent company at
California. Provided support to Manufacturing and Quality
Engineers during internal and external complaint
investigations. Maintained tracking of complaint
investigations.
Trainings
1994 - 2001
ASQ Certified Interamerican University Aguadilla, P.R.
Quality
Auditor Bachelor Degree in Business Administration (Major in
(Certification Management)
# 33525)
ASQ Quality
Auditor
Academia - ASQ Quality Auditor Academia - offered by American Society for
offered by Quality
American ASQ Certified Quality Auditor
Society for ISO 9001 Lead Auditor Training (CEEM/ ANSI-RAB accredited)
Quality P.R. Process Validation Tool Kit Seminar - offered by Becton
Chapter Dickinson
ISO 9001 Lead Principles of Lean Manufacturing Training - offered by P.R.
Auditor Manufacturing Extension
Training Modern Supervision for the High Competitiveness - offered by
(CEEM/ Quality Business for Success
ANSI-RAB Excelling at Managing People Workshop - offered by Skill Path
accredited) Seminars
Process Internal Audit: Best Practices using the FDA QSIT model -
Validation offered by Business
Tool Kit Excellence Consulting
Seminar - Supplier Certification: How to Establish an Effective Program
offered by - offered by Business
Becton Excellence Consulting
Dickinson Effective CAPA Systems - offered by Business Excellence
Principles of Consulting
Lean Human Error Identification - offered by Business Excellence
Manufacturing Consulting
Training - Six Sigma Fundamentals - offered by Honeywell Aerospace
offered by SSGB Core Training - offered by Honeywell Aerospace
Puerto Rico Certified Six Sigma Green Belt - offered by Honeywell
Manufacturing Aerospace
Extension
(PRIMEX)
Modern
Supervision
for the High
Competitivenes Available upon request.
s - offered by
Quality
Business for
Success,
Inc.(QBS)
Excelling at
Managing
People
Workshop -
offered by
Skill path
Seminars
Internal
Audit: Best
Practices
using the FDA
QSIT model -
offered by
Business
Excellence
Consulting
Supplier
Certification:
How to
Establish an
Effective
Program -
offered by
Business
Excellence
Consulting
Six Sigma
Fundamentals -
offered by
Honeywell
Aerospace
Effective CAPA
Systems -
offered by
Business
Excellence
Consulting
Human Error
Identification
- offered by
Business
Excellence
Consulting
SSGB Core
Training -
offered by
Honeywell
Aerospace
Certified Six
Sigma Green
Belt - offered
by Honeywell
Aerospace
Senior Member
of the
American
Society for
Quality (ASQ)
(Membership #
63367154).
References
Available upon
request.
Education
Contact this candidate