Robert Ritterbeck

act0au@r.postjobfree.com - Cell: 440-***-****

Northeast Ohio 44321

FDA, Complaint Analysis, Medical Device, Investigation, Engineering Technician

Partial Skill Set

FDA Remediation

FDA 21 CFR 820 Quality System Regulations

GMP

Medical Devices

Complaint Management

Post Market Complaint Investigations

Cross Functional Team

MDR’s

Decision Trees

DHF’s

Regulatory Affairs

Team Lead

System Test. Calibration, Verification, Validation

CAPA

SOP’s

ISO 13485

ISO 9000

Remediation

New Ventures

Root Cause Analysis

EMPLOYMENT

Philips Healthcare (Consultant) Mayfield Heights, Ohio 2015

Quality Regulatory Engineers, FDA Investigations

Post Market Complaint Investigation Specialist

Investigate, evaluate, complete and track complaints through handling process.

Coordinate with investigators providing missing information for root cause activities.

Collaborate with Engineering, Field personnel, Customer Support, and other appropriate groups for initial evaluation of complaints

Review and complete investigations for accuracy and completeness of investigations of

CT and Nuclear Medicine Scanners. Duties included verification of information gathered

for correctness and writing conclusion statement of investigations including engineering

investigations and cross reference to CAPA database if applicable.

Convatec, (Consultant) Greensboro, North Carolina 2014-2015

Quality Regulatory Engineer, FDA Investigations

Complaint Investigations Specialist

Review and approve co-workers work for accuracy and completeness of investigations

including trending analysis per Convatec policies and FDA compliance before attaching

information via Convatec Quality software for FDA compliance.

Greatbatch Medical, (Consultant) Ft. Wayne, Indiana 2014

Quality Regulatory Engineer, DHR (Device History Report) Remediation Project

Review, remediate and gather relevant information pertaining to DHR (device history record) files to ensure compliance with government regulations, ensure correct and complete documentation and file noncompliance reports as needed.

Completed assigned project two weeks before due date.

Assisted with complaint and CAPA remediation projects as needed.

Invacare, (Consultant) Elyria, Ohio 2013

FDA MDR (Medical Device Report) Investigation/Volume Filing Specialist

Researched/Remediated/coded and filed Post Market Complaints per CFR Title 21 Section 820 to the FDA for varied Medical Devices per Invacare operating procedures.

Approved and submitted peers MDR’s directly to the FDA.

Rejected Complaints with incomplete information before submission to FDA.

Notified manufacturing facilities, distributors and business partners within the US and around the world of FDA filings via Email. Responded to questions per Invacare policies.

Lead MDR team in Post Market filings (2nd Quarter) investigated, coded and filed to the FDA

Philips HealthCare, (Consultant) Mayfield Heights, Ohio 2012

FDA Audit-Field Service Engineer Consultant/Complaint Handler/Investigator

Diligently Researched/Remediated average 250 per day Post Market Complaints for FDA Report-ability Pursuant to CFR Title 21 Section 820 and using Philips Hazard-Harm Matrix within the CT/NM Business Unit / Quality and Regulatory. Complaint Intakes and proper documentation into system.

Strong Interpersonal, Written and Communication Orientations used to clarify complaint issues with Engineers, Technical, Service and Medical personnel within the decision making process.

Abstracted / Analyzed information from Blueprints, Schematics, Technical Writings, Manufactured Histories, Technical Journals and applying/comparing to customer complaint within the decision making process.

Reading, Interpretation and Application of Federal Codes as well as foreign medical mandates, ISO 13485 and IEC 60601, using Analytical, Problem Solving and Critical Thinking Processes to arrive upon Defend-able Decisions.

Using Hazard Harm Matrix coded Complaints to degree of severity for report-ability to FDA/

Good Documentation Practices Implemented and Utilized.

Worked within strict time constraints while organizing/prioritizing tasks in timely manner.

Maintain awareness of advances in medicine, computerized diagnostic and treatment equipment, data processing technology, government regulations.

Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents.

Zetta Medical 2011

Diagnostic Imaging Field Service Engineer

Primary systems of responsibility included Philips MRI Achieva, Philips CT Brilliance family, Marconi MX8000, secondary MRI Toshiba Vantage and MRI Siemens Harmony, assisted with CT Toshiba and GE CT products.

Out of industry 2010

Neuisys Imaging Systems Solution 2009

Diagnostic Imaging Field Service Engineer

Interfaced directly with Chinese engineers and escort for system requirements and US expectations on Philips Neusoft CT and MRI Systems

Philips Healthcare / Marconi / Picker International 1997-2000, 2004-2009

Diagnostic Imaging Field Service

Performed routine/preventative service, fields change orders, installations, audits and emergency service on field installed systems. Primary systems included CT Brilliance family, CT MX8000 family, MRI Intera/Achieva, MRI Infinion, MRI Eclipse, CT PQS, MRI Outlook/Proview, and Gemini PET/CT. Perform system verification and validation of newly installed systems as well as mandatory Fco’s and modifications.

Secondary duties included monitoring for field service manager on scheduling issues to ensure regulatory requirements and staffing to address field service team duties.

Factory Refurbishment Engineer

Receive trade-in and purchased CT and MRI products of Philips Healthcare design. Audited, disassemble, reassemble and install all hardware, software, and required regulatory field modification. Performed all calibrations and a complete Quality Performance analysis to ensure refurbished units functioned at the highest/current revision levels as new models.

Specialize in 1.5 and 3.0T MRI Philips products. Travel when required to assist with installations to ensure a smooth transition to the customer installed database.

Multivendor Diagnostic Imaging Field Service

Perform routine field service duties on GE /Siemens MRI products for Picker/Marconi International and support CT/MRI products of OEM design.

DNA Center of Daytona / Daytona Radiology / Daytona Oncology 2002-2003

Facility Diagnostic Imaging/IT In-house Engineer

Maintain radiology and oncology equipment consisting of 2 MRI (GE/Picker), 3 CT (GE/YMS), Radiation Oncology (Varian) and a 40 workstation network with server.

MasterPlan 1994-1996, 2000-2001

Regional Senior Diagnostic Imaging Support Engineer

Maintain GE CT/MRI product in a service area from Dallas to NYC to Atlanta

Innoserv 1992-1993

Diagnostic Imaging Field Service Engineer

Solely maintained entire state of RI GE MRI Imaging network, a 3 man working model, 2 man revenue model account.

Technicare / General Electric Medical Systems 1979-1992

MRI Installation Specialist

Install GE/YMS MRI systems from delivery to point of acceptance.

Diagnostic Imaging Field Service Engineer

Maintained GE/Technicare MRI/CT imaging equipment. Received GE Hall of Fame award as voted Best of Best Service Engineer as rated by customers and peer engineers.

Manufacturing Technical Leadman

Working group lead, trained production department on troubleshooting techniques to component level and scheduled activity of more than 30 technicians to meet production schedule on digital angiography products.

New Ventures Production Engineer

Worked directly with design engineers and assisted with technical writers to develop Technicare digital angiography products while preforming test and calibration of new products.

Production Imaging Technician

Repair to component level, calibrate and test subassemblies for Technicare CT products.

Received accelerated advancement for cutting test cycle from three weeks to three days.

United States Navy / Reserve 1976-1982

Electronic Technician Specialist, Honorable Discharge 1982

Specialize in UHF/VHF communication equipment. Received Sailor of the Month award for Outstanding Rating test scores. Active duty 1976-1979, Reserve 1979-1982.

Education

Original Equipment Manufacturer Diagnostic Imaging Service Schools 1982-2006

More than 108 weeks in manufacturers technical schools on CT/MRI/Nuclear products including theory of operation, physics, troubleshooting techniques and image quality/performance issues.

Florida Junior College / Akron University 1979-1982

Accumulated more than 100 credits toward Electrical Engineering

United States Navy 1976-1979

Electronic Technical Certificate and Electronic Specialist Schools for RF communication equipment plus various self-paced military sponsored technical training courses.

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