Qualifications Skills: Regulatory Affairs/quality assurance: Projects, related skills and practice include: * Prepare and submit 510 (k) s for US FDA on Class I and Class II Medical Devices and assisted with the preparation of Class III submittals * Compile, document and submit Technical Files for Europe (CE Marking) per Medical Device Directive (MDD) * Perform monthly trending analysis * Developing quality systems plan including Design Controls * Quality systems management * Develop quality systems manual and procedures * Evaluating test results * Well versed with ANSI, ISO, EN, IEC and 21 CFR part 820 standards Process Design: - Review for inclusion to FDA, CMDCAS, Therapeutics, ANVISA and MDD Guidelines * Analyze and review Risk Analysis (FMEA, FTA) for completion and accurracy * Assist in the design of new products such as catheters, portable aspirators and medical lighting * Establish testing and measuring protocols for components, subassemblies and finished devices Administration: * Ensuring compliance with North America (US, Canada), Australian, Brazilian and European established regulations (FDA, MDD, ANVISA, CMDCAS and CE marking) * Preparing technical reports and documentation * Ordering lab equipment and supplies * Maintain/Create/Execute Department Budget * Write, execute and report findings on IQ, OQ, PQ and PPQ protocols as required for machines, test and manufacturing equipment and processes Computers: * Utilizing Windows - based PC with software JDE, Microsoft Office, Access, Word, Excel, Outlook * Assisting in development of 21 CFR Part 11 compliance program Accomplishments/ - Trained individuals of the BWI Rec. Insp. group in GD&T, ANSI Y14.5M - Took both Burton and SSCOR to ISO 9001and ISO 13485 registration within a short period of time. - Introduced the electronic record keeping principle to SSCOR and instrumental in identifying and procuring the software currently in place at SSCOR for this purpose.

Highlights:

• Manufacturing
• Medical
• Medical Devices
• Risk Analysis
• Documentation
• Failure Analysis
• ISO
• Quality Assurance
• Quality
• Statistical Analysis