Engineer Quality
Resume:
Paul Foderick
Coral Gables, FL **134
********@*********.***
www.linkedin.com/in/paulfoderick
SUMMARY
Results-driven database engineer with over 15 years of experience with Fortune 50 medical device companies and Safety Surveillance and Regulatory Agencies worldwide. Strong skills in preparation of quality system requirements, development, and compliance under strict deadlines. Extensive application development with data integrity and auditing. Skilled reporter in analytics with reputation of setting industry standards.
Quality System Processes Combination Products Improved Product Safety
FDA & EMEA & BSI Audits Pre & Post Market Approvals Customer Retention Planning
PROFESSIONAL EXPERIENCE
Cordis (Cardinal Health), Miami Lakes, FL 2015 - 2016
Data Engineer
Managed upgrades to software revisions for dashboard metrics and validated decision trees according to customer specifications.
Validated SAS software program.
Defined reporting requirements for implementation of global complaint-handling system implementation for Cardinal.
Reduced ad-hoc reporting redundancies by 30% by formulating precise database queries.
Produced management review presentations on a monthly basis for five manufacturing sites and 12 OEM suppliers.
Successful, on-time implementation of MDR Requirement 21 CFR 803.
Reduced report frequency 20% by training users in Excel formatting techniques such as pivot tables in order to implement a self-service operation.
Cordis (Johnson & Johnson), Miami Lakes, FL 2003 - 2015
Reporting Specialist I & II
Designed templates for complaint trending and statistical methods across Cardiovascular/Endovascular/Neurovascular product suite of 20,000 products for a $4 Billion company.
Produced 100% of pre-market, post-market vigilance reports for safety surveillance.
Ad-hoc reporting precision produced consistent MDR submission benchmarks at 99% - setting the standard in the industry.
Supported CAPA process and closure by providing complaint monitoring.
Verified data integrity for all Regulatory MDR/MDV vigilance reports.
Streamlined metrics on Failure Analysis reporting of returned products.
Assisted with validation of complaint escalation, severity-based trending and implementation of MAUDE codes in complaint handling database.
Vital UAT tester and architectural designer for metrics and dashboards for two complaint databases implementations for Cordis, one being for the Medical Devices business segment.
Successfully launched eMDR system and electronic datasheet for accurate collection of data.
Responsible for MDR Similar Event report submissions for OUS countries.
Paul Foderick 305-***-**** Page Two
EDUCATION / TRAINING
Degree, Field of Study
University of Minnesota-Minneapolis, English Literature, B.A., Minneapolis, MN
Technical Skills
Access, Crystal Reports, Quality and Safety Compliance
SAS Experience CAPA Support Product Engineering
Software Revision OBIEE SQL Analytics ISO 13485
ADDITIONAL RELEVANT INFORMATION – USE APPROPRIATE SECTION HEADING
Achieved performance award from developers for UAT testing on dashboard analytics for One Voice/Patient First implementation in 2014.
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