Quality & Regulatory Inspector Candidate
Resume:
JOSEPH CALIFANO
Santa Clarita CA, 91350
Phone 973-***-****, email ******@*******.***
OBJECTIVE
Experienced Quality Technology professional seeking employment in a relevant technical field.
EXPERIENCE
Chilton Medical Center Pompton Plains NJ
May 2023 to October 2023 Volunteer,Clinical Engineering Group
Duties include assisting engineers with equipment documentation
Updating equipment databases to assure connection to applicable regulatory approvals/clearances.
Sabbatical February 2020 to May 2023
Provided at-home and outside medical support to my wife.
Hydromer, Inc. Branchburg NJ
March 2004 to January 2020 Manager, Quality Assurance, Chemical Formulation
Managed ISO 9001(2015) certified Quality System (QA, QC, QE)
Management Representative
Managed QA Analytical Chemistry Laboratory
Facilitated local, state, national, and international regulatory filings, submissions, and certifications (FDA, EPA, EU, DOT, OSHA, NJDEP)
Corporate Safety Officer
Bayer Healthcare LLC, Tarrytown NY
June 2002 to October 2003 Director, Regulatory Affairs
Responsible for global regulatory compliance, submissions and registrations
FDA Official Correspondent
Clinivation, Framingham, MA
July 2001 to October 2001, Consultant, Regulatory Affairs/Quality Systems
Prepared and submitted 510 (k) premarket applications to FDA for client customers
Mosaic Technologies, Inc Waltham MA
August 2000 to June 2001, Director, Regulatory Affairs/Quality Systems
Responsible for the development and implementation of a viable Quality Management System in accordance with ISO 13485
Responsible for the establishment of relationships with appropriate regulatory agencies
Hemagen Diagnostics, Inc, Waltham MA
September 1993 to July 2000, Director Regulatory Affairs
Responsible for the development and implementation of a global regulatory function
Official FDA Correspondent
Preparation and submission of required regulatory filings submissions, and certifications to applicable local, state, federal, and international agencies.
Managed the Quality Assurance Department
Conducted scheduled Quality System audits of several US manufacturing sites.
EDUCATION
B.A. Physics/Chemistry Hunter College (CUNY) June 1972
ASQ Certified Quality Engineer (CQE) #8818 June 1982
Previous Professional Experience (1974 to 1993)
Millipore Corporation,Bedford MA
December 1985 to August 1993, Senior Quality Assurance Engineer
Gelman Sciences, Ann Arbor MI
December 1979 to March 1982, Manager, Quality Control
April 1982 to November 1985, Quality Engineer
Amicon Corporation Lexington MA
January 1978 to November 1979, Manager Quality Assurance/Regulatory Affairs
Pall Biomedical Corporation, Glen Cove NY
March 1975 to December 1977, Manager, Quality Control
March 1974 to March 1977, Laboratory Technician Hydraulics Research Laboratory
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