Jake Essig FDA QA Engineer - 3May2016
- 1. JAKE ESSIG [email protected] 7012 Dardinelle Place, Wendell, NC 27591 (919) 696-3535 (cell) SUMMARY OF QUALIFICATIONS 1 2 Quality Engineer for several years in the Medical Device industry. 3 Involved in the processes covering the entire Medical Device lifespan (New Product inputs through Post Market field activities) 4 Worked with the following processes: • 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), • Software Quality Assurance and Testing (Black box & white box, Manual & automated (e.g QTP, ALM, etc.). 5 6 Assured compliance to internal procedures (SOP, Work Instructions, etc). 7 Assured that internal procedures complied with external standards and did not conflict with each other. 8 9 Assured compliance to external US, European, and ISO standard such as : 10 CFR Title 21 Parts 820, 803, 11, ISO 13485 & 14971, and IEC 60601-x as a minimum Recent Technical Training 11 Six Sigma Green Belt certification - Villanova University. EXPERIENCE Quality Engineer, 12/14 to 1/16, Becton-Dickinson, Mebane, NC • Performed complaint investigation on Class II and III medical devices • Assured compliance with 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 • Reviewed manufacturing procedures to limit potential failure modes • Used SAP as the and TrackWise as the documentation and data repositories
- 2. Quality Engineer, 8/13 to 12/14, Depuy-Synthes, West Chester, PA • 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 Effectiveness Monitoring • Audited internal (corporate) procedures to assure compliance with Design control process and assure clarity and regulatory compliance. • Created Management Review statistics used to measure effectiveness 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 Management Review presentations. • Software used: WindChill, Etq, CATSWeb, Docusphere, SharePoint, etc. Advanced Quality Engineer, 2/13 to 7/13; Stryker Spine, Allendale, NJ • 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. • Maintained Design History files via Windchill document repository for the Risk related documents Validation Engineer, 6/12 to 12/12; Hill-Rom, Batesville, IN • 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). System Analyst, 11/09 to 01/12; CACI inc., Chesapeake, VA • Tested Electronic Health Records software applications used by the Navy and other military services. • HIPAA certified to process live medical records. • Wrote Requirements, Test plans and cases using HP Quality Center V11 for legacy applications. • Verified compliance with documented business requirements and rules. Quality Engineer, 09/07 - 11/07; Plexus, Raleigh, NC • 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 within two weeks.
- 3. System Quality Analyst, 03/07 - 09/07; Blue Cross & Blue Shield of SC, Columbia, SC • 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 then documented the development and quality assurance processes. • Coordinated all change processes, and testing activities, from unit through user acceptance (UAT). Process Validation Engineer, 05/06 - 12/06; Boston Scientific, Glens Falls, NY • 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 with 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 within the project. Design Validation Engineer, 5/05 -12/05; Baxter Healthcare, Largo, FL • Executed design Verification protocols for a legacy medical device. • This included (but not limited to) software, pneumatic end electrically controlled equipment. • Performed experiments and analyzed collected data to solve CAPA issues. • Provided several methods of improving the validation process. • Followed following FDA CFR parts 820 & 11, ISO 13485 and IEC 60601-1 • Wrote design requirements and test cases using Doors software for new products. Lead System Quality Engineer, 05/00 - 08/04; Eastman Kodak, Rochester, NY • Managed a team testing a web-based software application, used as a diagnostic tool for a digital color press. Application used to monitor, maintain, calibrate and repair the press, by end users and Field Service engineers. • Developed the testing process even though formal requirements and design documentation were initially unavailable. • Performed electrical calibration and mechanical maintenance procedures to verify Field Service procedure accuracy. • Wrote and maintained test documentation (plans, cases, matrixes, defect tracker, etc.). • Compiled and presented test data statistics for periodic product assessments. Computer System Validation Engineer, 08/99 - 05/00; Bausch & Lomb, Rochester, NY • Wrote and executed Computer System Validation procedures in this FDA regulated company. • Developed the test process to assure compliance with as FDA CFR Title 21 Parts 11. • Validated the Documentum document control software assured compliance with FDA regulations. • Installation was via a Novell Network supporting multiple platforms and Operating systems. EDUCATION University of Phoenix, Phoenix, AZ, BS Business Administration Rochester Institute of Technology, Rochester, NY, BS Electrical Engineering
- 4. Monroe Community College, Rochester, NY, AAS Electronics Technology