Nicholas C. Rodes

Quality Systems Analyst at DJO Global

acn37v@r.postjobfree.com

Summary

Degree in Bio-Medical Engineering and 3+ year’s professional experience in Medical Device Quality

Systems. Expertise in complaint handling, MDR triage and filing through FDA, CAPA

Initiation/Implementation/VOE/Closure, NCMR classification, and Quality Software design. Highly

efficient using Excel/ PowerPoint to take data from CAPA, Complaints, NCMR, and Failure Investigations

to provide immediate solutions to current initiatives while also forecasting future trends. Strong affinity for

professional technical writing and Software power-user with: Agile PLM, Salesforce, SharePoint/uniPoint,

FDA MDR eSubmitter, Oracle, Vantage, Trackwise.

Professional Experience

Quality Systems Analyst at DJO Global

April 2014 - Present

- Use Agile PLM, uniPoint, SharePoint, and PCR to evaluate and close both injury/ quality complaints;

provide detailed analysis of the product class/ failure mode to create useful backend data

- Work with management to customize Agile PLM design and functionality by completing detailed Business

Requirements with justification, risk assessment, and data validation

- Determine if an MDR filing to federal & international regulatory bodies is required by working with

Regulatory Affairs to provide Failure Investigations/ Patient Questionnaires

- Lead team of analysts in processing and closing Complaints, CAPAs, and NCMRs on Agile PLM

- Provide detailed VOQ/ QMR data analysis on open CAPAs and ongoing unresolved NCMRs across DJOs

worldwide locations; coordinate CAPA completion across eight different divisions by providing guidance

and direction during the life of a CAPA

- On a weekly basis, consolidate all relevant Quality data into a custom excel dashboard with accompanying

PowerPoint presentation via metrics presented in tables, graphs and charts

QC Analyst II at SynergEyes

2013 - 2014

- Process incoming complaints via current ISO 13485 MDR filing regulations; all returned lenses are then

visually inspected, the base curve & power are measured, and the associated complaint is closed

- Oversee release of all incoming raw materials and outgoing finished devices

- File Non-Conformance reports and participate at Management Review Board meetings giving feedback on

design and implementation of quality system

- Collaborate with manufacturing, marketing and logistics to ensure optimal efficiency and quality of all

devices manufactured on site as per current ISO 13485 GMP regulations

- Provide analysis on the implications of complaint trends and their impact on all devices in the field

- Monitor manufactured design specifications as per the FDA Quality System Requirements

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QA Compliance Associate at Tandem Diabetes Care

2013

- Medical device complaint handling both prospective and retrospective case log

- Analyze complain data and take appropriate action to resolve case and organize CAPAs

- Provide accurate and current understanding of FDA compliance information including Failure

Investigations, Complaint Trending, and Medical Device Reports

- Develop Risk Analysis for Hazard IDs associated with potential risk, predetermined assurance cases and

current Complaint Categories

- Cumulative analysis and creative development of Quality System with an emphasis on maintaining

acceptable risk to the end user/ patient

Product Support Associate at Alere, Inc.

2012

- Categorized and processed complaint investigations from product returns by equipment and procedure

analysis, prioritizing conclusions according to safety and reliability standards

- Processed therapeutic blood samples on SYSMX analysis device, and networked results with quality

assurance team members to complete case reviews

- Conducted normal and high priority case analysis on the SALESFORCE network

- Investigated INRatio meter functional tests and conducted comparative visual inspections

- Maintained trending data on blood sample strip lots, and analyzed correlations and confidence limits

Education

University of Southern California

- Bachelor of Science (B.S.), Biomedical/ Medical Engineering, 2012

- Activities and Societies: Sigma Chi Fraternity, Biomedical Engineering Society (BMES), Sigma Alpha

Lambda-National Leadership and Honors organization.

Skills & Expertise

Quality/ Regulatory Software Practical/ Analytical Skills

CAPA Owner & Admin Oracle Agile PLM Microsoft Office Super User

MDR Decisions & Reporting Salesforce & CRM Custom Excel Dashboards

Complaint System Design uniPoint & SharePoint Statistical Data Analysis

Risk Analysis & Human Factors Matlab & LabView Reporting & Trend Analysis

Quality Control Inspections Crystal Reports Business Requirements

ISO 13485 & ISO 14971 Adobe Acrobat Pro Technical Writing

Failure Analysis/ pFMEAs Qlikview Diagram Internal & External Auditing

Deviations and ECOs Vantage NCMR Trending and Closure

Contact Info

Email: acn37v@r.postjobfree.com

Professional references from all previous employers are available upon request.

Contact Nicholas on LinkedIn

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