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MARIFRANCES
CATALDI
1699 Koshkonong
Rd.Stoughton, Wisconsin 53589 - 608-873-5588
Quick study, self-motivated
Quality professional with 8 years experience in test design and
problem resolution in a federally regulated manufacturing
environment. Excellent communications skills, careful attention
to detail, organized, scientific method well understood.
Developed the processes and controls of a Product Validation
department where none previously existed. Reputation for
integrity and hard work.
EDUCATION
- BS pre-med (majors: biology
and art, minor: chemistry), Mount Mary College, 1975,
Milwaukee, Wisconsin
- AAS Electronics Engineering,
Wisconsin School of Electronics, 1988, Outstanding
Student Award, A+ average
- certification: Certified
Validation Professional through The International
Validation Forum, 1996
SKILL
SUMMARY
- Scientific method used
for 8 years in the development of test plans.
- Analytical and organizational
skills used to create, implement and successfully manage
a federally mandated test department, with minimal
supervision.
- Careful attention to
detail used daily to document an auditable trail in a
federally regulated manufacturing environment.
- Created SOPs and
documented the processes and controls mandated by ISO
9001 and GMPs.
- Creative approach to negotiation
and problem solving.
- Decisive
prioritization in an environment demanding multi-tasking.
EXPERIENCE
Burdick Inc. Milton,
Wisconsin (10/88 to 10/96)
(Formerly Siemens Burdick
Corporation) A manufacturer of electro-mechanical cardiac medical
devices worldwide sales exceeding $50 million.
Manager of Product
Validation (Feb. ‘96 to 10/96)
- Reported to Vice President of
Operations.
- Creation of the processes and
controls of a product validation test department.
- Responsible for the
recommendation of release of engineering prototypes to
the production floor and, subsequently, the marketplace.
- Prevented products with
failures from reaching the market place despite pressure
to release products quickly.
- No product deficits were
reported through customer service that had not been
reported and documented by the product validation test
department prior to product release.
- No successful product
liability suits or recalls of devices tested by product
validation.
- Design of comprehensive
validation test suites, based on internal product
specifications, hazard analyses, federal requirements and
industry-wide recognized standards (AAMI).
- Designed internal standard
for automated testing of embedded systems, LabView.
- Through collaboration with
Engineering, products were designed for testability.
- Created ISO 9001
documentation and SOPs (standard operating procedures)
for GMP environment.
- Clearly documented test
processes and results, facilitating passage through FDA
and ISO audits.
- Managed the compiling and
archiving of test results and product release
documentation.
- Designed and maintained the
internal defect tracking database.
- Passed internal and external
GMP and ISO audits without deviation.
- Hired, trained and managed
test lab staff; clerical, technicians and electrical
engineers.
- Negotiated with Engineering
and Management for product deviation resolution.
Supervisor of Product
Validation (Feb. ’93 to Feb. ‘96)
- Professional Accountability
and responsibilities as documented above.
Engineering technologist
(March ‘89 to Feb. ‘93)
- Reported to Engineering
manager.
- Began the development of the
product validation process.
- Supervised several temporary
testers.
- Built engineering prototypes.
Incoming Inspector
(Oct ‘88 to March ‘89)
- Reported to QA Supervisor.
- Inspected and
accepted/rejected received materials in accordance to
company blue prints.
Self-employed artist and
student (3/60 to 10/96)
- Designed and produced
stoneware clay animals.
- Won many local awards.
Medical College of Wisconsin
Milwaukee, Wisconsin (8/77 to 3/80)
- A medical college and human
life science research center.
Biochemistry technician
- Reported to Ph.D.
principal investigator.
- Ran and analyzed the
chromatographic assays necessary for the amino acid
sequencing of a protein.
- Performed enzyme assays.
- Stocked the lab.
- Weighed chemicals, prepared
solutions.
- Worked with analytical lab
instrumentation.
- Kept the federal NIH grant's
account books.
Children’s Hospital
Milwaukee, Wisconsin 9(75 to 6/77)
- A pediatric hospital and
medical research center.
Biochemistry technician
- Reported to MD. principal
investigator.
- Standard biochemistry
technician duties as documented above.
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