PROFESSIONAL SYNOPSIS
• Excellent communication and writing skills
• Strengths include analytical, biology and chemistry techniques, attentive, detail oriented.
• Fluent in foreign language.
• Six Sigma training
CORE COMPETENCIES
Microsoft Office
Word
Excel
PowerPoint
Access
Visio
Sequencing
PCR amplification
SAP BI 7.0/BW 3.5 Java and Perl programming
PROFESSIONAL HISTORY
Quality Engineer
Working as Quality Engineer in fast pace environment to assure product quality in terms of adherence to, and continuous improvement of, the company’s Quality Management System in accordance with the official bodies.
MRI Global/Mela Sciences Inc., Irvington, NY 1/14 - Present
• Ensures implementation and maintenance of the effectiveness of the Quality System to meet Regulatory requirements, ISO13485, CE (European Regulatory), FDA QSR/cGMP, and internal requirements.
• Assisting in the organization and maintenance of Quality Management System.
• Develop and monitor Quality goals and objectives for services and processes.
• Assist Product Development with Design review, Specification development, and Verification and Validation protocol and reports (IQ, OQ, PQ).
• Creates, maintains, and implements SOP’s with necessary forms and technical files.
• Assist in maintaining Design History File, Device Master Record, and Device History record.
• Facilitates and manage Change Order Process( e.g. ECN)
• Provide field failure analysis support with support of Product development and manufacturing, Non-Conforming Material, and Return Material Authorization process control and disposition.
• Support and ensure CAPA system is in compliance with the requirement by assisting in root cause analysis and timely completion of the CAPA.
• Coordinate language translations activities and facilitate the approval and release of labeling materials within project deadlines and in accordance with procedural and process requirements.
• Write labeling content for medical device software or hardware under development by utilizing design documents, labeling requirement specifications, and prototypes or user interface simulators.
• Facilitate the risk management program and maintain the company’s risk management files.
• Responsible for trending the complaint data and act as management representative to present it.
• Act as liaison and facilitator between various functional groups to ensure Marketing promotional materials reach for demonstration accurately and timely manner.
• Perform internal and supplier audits and maintains audit plans and schedules.
• Assist in the FDA and European audits and determine and implement proper corrections for the audit findings.
• Responsible in determining and maintaining training for the company.
• Assisted in Software testing (Manual testing, Black box testing , Regression testing, CRM)
o Developed, implemented and executed system, unit and integration tests.
o Maintain tests that conform to system requirement. Performed system level tests on continuous basis.
o Performed defect tracking using TestTrack by reproducing issues, verifying fixes.
o Maintain release cycle procedures and scripts.
o Support Software developer in testing
Quality Compliance Specialist/ Engineer
Working as Quality specialist in fast pace environment to ensure compliance of quality and regulations as per official bodies.
Aerotek/ Immucor Transplant Diagnostics, Inc., Stamford, CT 9/13 – 12/13
• CMDR and the European IVD Directive (98/79/EC).
• In conjunction with the Site Leadership Team, responsible for creating awareness of and compliance with the Quality System
• Ensure compliance for the final release of IVD products.
• Ensure Documentation Control Program in compliance with requirements
• Ensure CAPA Program in compliance with requirements
• Oversees Change Control compliance through Engineering Change Request/Notice (ECN)
• Co-ordinates Internal Audit Program and maintaining audit schedules and files
• Provides New Employee Training on Immucor Transplant Diagnostics, Inc.’s QMS
• Assisted in validation of new processes and equipment.
• Assist in organizing, presenting trend analysis and maintaining records
• Responsible for Management Review of the QMS, including organizing, presenting trend analysis and issuing minutes of the Quality Council Meetings
• Acts as Management Representative for regulatory and certifying bodies
• Responsible for the regulatory submissions required for IVD products in areas they are sold.
• Act as a Document control officer for approval of various business, quality, engineering, and R&D documents.
Post Market Quality Analyst (PMQA) & Vigilance Investigator/Analyst II
Worked as PMQA analyst to gather and process customer complaint information by analyzing previous year’s trend data and evaluating the return products for user or assembly errors.
Judge Staffing/Covidien, New Haven, CT 4/12 to 08/13
• Maximize productivity by setting clear expectations and proactively communicating project status, issues and risks to management.
• Gathered and processed information on returned complaints and documented the data in Complaint Tracking system (CTS) and, ensured proper solutions via Corrective and Preventative actions (CAPA).
• Evaluated, independently, clinically applied surgical devices of various degrees of complexity to determine root cause analysis in compliance with GMP, ISO, QSR, FDA, and International Regulatory requirements.
• Report MDR/MDV event to the analytics group based on the receipt of the physical product received.
• Prepared and maintain technical investigation reports and documents based on results of evaluation and review of the manufacturing plant reports to be documented in the CQA (Quality Assurance) Department complaint database and incorporate into customer response letters using software’s such as BPCS, ERP, Agile, and, Microsoft SharePoint, and Microsoft office.
• Worked with research and development engineers, quality engineers, regulatory affairs, and manufacturing on root cause analysis and provided a written report.
• Identified the appropriate test method/regiment from existing Standard Operating Procedures for complaint sample evaluation and interpret the data for definitive root cause analysis determination.
• Assist in writing test procedures, operating procedures, local instructions, and test protocols.
• Assist in qualification and validation of equipment and processes.
• Review and document Trend information to determine the need for CAPA on a daily basis.
• Initiated and distributed Corrective Action Requests to Manufacturing or Engineering Departments as needed.
• Assisted in projects such as creating Standard Work Ins...
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