Paul Foderick

305-***-****

Coral Gables, FL **134

acyljb@r.postjobfree.com

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.

Contact this candidate