SUMMARY:

• Quality Engineer for several years in the Medical Device industry.
• Involved in the processes covering the entire Medical Device lifespan (New Product inputs through Post Market field activities).
• Documented customer needs,
• DHF initiation and maintenance
• Functional and Design Requirements,
• Risk Analysis, dFMEA,
• Design Verification and Validation,
• Design Change process,
• Design Transfer,
• Manufacturing Process Validation (IQ OQ PQ, PV, pFMEA), Equipment Calibration and Periodic Maintenance,
• Manufacturing and supplier Non - conformances - analysis
• Post Market surveillance (Complaint Handling, HHE, investigation, Field Actions, Risk Management), Post-market Design Changes, CAPA processing,
• Computer System Validation,
• Engineering leadership (e.g. lead, supervisor, manager),

PROFESSIONAL EXPERIENCE:

Senior Quality Engineer

Confidential, Durham, NC

Responsibilities:

• Performed complaint investigation on Class II and III medical devices
• Assured compliance wif internal procedures and 21 CFR 820.198 and 820.200
• Performed root cause analysis of supplier and manufacturing non-conformances and complaint related returned products
• Initiated and monitored CAPAs due to increased failure rates
• Reviewed manufacturing procedures to limit potential failure modes
• Used SAP and TrackWise as the documentation and data repositories

Senior Quality Engineer

Confidential, West Chester, PA

Responsibilities:

• implemented new Design Control processes and documentation to assure regulatory compliance and address inter and external audit findings
• Developed training material on updated Design Control process
• Processed and completed related CAPAs Actions and performed TEMPEffectiveness Monitoring
• Audited internal (corporate) procedures to assure compliance wif Design control process and assure clarity and regulatory compliance.
• Created Management Review statistics used to measure TEMPeffectiveness and timeliness of the existing Quality
• Management System (QMS). These metrics to be used as a baseline to see trends after process improvements.
• Reviewed and assessed legacy documentation related to Manufacturing Non-conformance, Complaints Management, Field Actions, CAPA processing, Supplier Performance, and Service and Repair activities.
• Used advanced features in MS Excel, Access, and PowerPoint to develop the metric data, graphs and charts, and

Advanced Quality Engineer

Confidential, Allendale, NJ

Responsibilities:

• Project: Performed Risk Analysis and Evaluation on Class 1 & 2 medical devices.
• Performed design reviews for custom designed and manufactured surgical Instruments
• Analyzed manufacturing non-conformances and assessed possible root causes, process issues, regulatory, issues, and potential risks to the users and patients.
• Performed Risk Analysis and Evaluation on Post-Market product based on complaint investigations.
• Performed Risk Analysis process Improvement by implementing Stature software integration.
• Followed ISO 14971 and several internal WIs and standards for numerous business processes
• Updated Risk Analysis process forms and wrote work instructions and training material for form use.

Validation Engineer

Confidential, Batesville, IN

Responsibilities:

• Project: Remediation for a Class 2 medical device.
• Followed FDA CFR part 820, ISO 13485, IEC 60601-1 and internal WIs and SOPs
• Created test requirements traceability matrix and template for design validation scripts
• Developed spreadsheet to collect and automatically analyze the validation data
• Reviewed the Design Requirements Spec to verify measurable product features.
• Wrote test scripts procedures to validate the Functional Requirements Spec (focused on evaluating if customer needs are being met by product design).

Quality Engineer

Confidential, Raleigh, NC

Responsibilities:

• Wrote dFMEA, pFMEA, and risk analysis documents for electro-mechanical medical devices.
• Edited design requirements, wrote and executed Test (Validation) Plans and Test Cases to make them clearer and more verifiable.
• Developed a proficiency in using a Requirements Management software application wifin two weeks.

System Quality Analyst,

Confidential, Columbia, SC

Responsibilities:

• Tested web based applications that provide healthcare insurance price quotes and claims processing status.
• Wrote requirements, test plans and cases using HP Quality Center for a several software applications.
• Worked on multiple projects concurrently.
• Discussed methods of using Six Sigma tools to perform Process improvement in the development and testing environments.
• Analyzed tan documented the development and quality assurance processes.
• Coordinated all change processes, and testing activities, from unit through user acceptance (UAT).

Process Validation Engineer

Confidential, Glens Falls, NY

Responsibilities:

• Wrote and executed IQ OQ protocols as part of an SAT and Process Validation project.
• Validated equipment used to manufacture FDA medical devices following FDA CFR parts 820 & 11, ISO 13485 and IEC 60601-1.
• Performed Risk Analysis per ISO 14971.
• Validated equipment included software, pneumatic and electrically controlled devices.
• Validated automated (programmable) equipment such as Allen-Bradley controlled.
• Analyzed pFMEA content and assured consistency wif the Master Validation Plan (MVP).
• Contacted manufacturers and internal designers to collect functional data for equipment when documentation was missing.
• Developed a database to eliminate duplicate effort wifin the project.