Easy QA Specialist Resume

Easy QA Specialist Resume Template
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(469) 656-1280 (Home)
(972) 757-8322 (Mobile)
HYPERLINK "mailto:garridosk@gmail.com"
Rich diversified background that includes U.S. FDA Inspector/Medical Device Specialist
in the areas of imports, biologics, food safety, prescription and OTC drugs and medical
device audits, inspections and investigations. Practiced 13 years as an independent
RA/QA consultant. Experience in Quality System (QS) development and/or
improvement in accordance with Federal Regulatory Compliance, 483 response, cGMP,
GCP, 510(k), IDE, and PMA projects. Corporate Quality Systems auditor for Fortune
500 medical device manufacturer. Actively managing the Internal Audit program and
providing site assistance with updating SOP (Standard Operating Procedures) content to
ensure US and International Medical Device and compliance. Expert Witness experience
includes acting as consulting expert in matters involving investigative medical device
failure during clinical trial, and mammographic-quality issues.
Currently preparing for Lean Six sigma Training.
Professional Experience:
1996–2009 US and International RA/QA Specialist-Consultant
Projects include:
Review and assist with restructuring of product design and development process.
PMA, IDE, 510(k) submissions, pre submission audits, in addition to international
Tech. Files and Design Dossiers
Labeling review (includes marketing materials)
Establishment Registration and Listing
Development and implementation of recall strategy and MDR/MDV activities.
DMR/DHF/DHR evaluation & improvement
Assure company’s policies, procedures, work instructions and documentation are in
substantial compliance with US (21 CFR, ANSI/ISO/ASQ Q9000-200), ICH E6, EU
(EN ISO 14971:2001, ISO 9001, 19011, 14969, 14001 and 13485, MDD (Medical
Device Directive), PAL, CMDA and SOR/98-282 regulations as they relate to the
design, manufacture, distribution and sale of regulated products.
CAPA Team Leader overseeing overhaul of deficient CAPA process and remediation
Develop and manage internal audit program.
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