CORE COMPETENCIES
QSR, ISO 13485, Extensive use of RCA tools (FTAs, Ishikawa diagrams, FMEAs, Cause & Effect, 5WHY, Pareto Chart), Trending reports, CAPAs, Field/Remedial Actions, NCR investigations, Design controls, V & V, IQ/OQ/PQ, MDR Reporting, Failure Analysis, Audit support, SPC, Risk Analysis and Management, Testing, FDA Medical device Regulations, MDD, AIMDD, IVDD, ISO Standards, Worldwide AE reporting, Process Improvements

WORK EXPERIENCE

Confidential, May 2011-Present
Quality Engineer, Complaints Analyst

• Lead and redefine the entire complaints process for improvements, clear documentation, timely MDR reporting and regulatory compliance
• Project leader for various CAPAs related to product quality, MDR reporting, trending
• Draft catch-up 510(k) sections concerning complaint trends, NCR trends and CAPA to demonstrate safety and efficacy of all design changes since original 510(k) clearance.
• Participate in cross functional teams for Hazard and Risk Analysis of product malfunctions using FMEA, FTA
• Investigate and evaluate product complaints for MDR reportabilty
• Train employees and new hires on complaints awareness and MDR regulations

Confidential, Irwindale, CA Jul 2009-May 2011
Complaint Handling Specialist

• Document, investigate, evaluate, report and process product complaints for worldwide regulatory compliance
• Serve as a Regulatory and Product Compliance Specialist for a family of class III medical devices
• Respond to requests from global regulatory bodies concerning adverse events and product performance
• Perform QE Review of complaint repair to ensure identification of root cause, resolution of complaint and compliance with worldwide regulations and ISO standards
• Perform failure analysis on electrophysiology catheters per established company procedures based on QSR (21CFR 820) and ISO 13485 standard
• Participation in HHEs to evaluate risk of product malfunctions for patient injury using statistical tools, complaints data, empirical analysis data and clinical assessments to use conclusion as rationale for not reporting
• Identify trends and review DHRs to identify the need for NCRs, SCARs, and CAPA
• Manage CAPAs, lead failure investigations and perform root cause analysis, develop mitigation measures and evaluate their effectiveness with DMAIC method
• Develop and revise standard operating procedures, test procedures and validation protocols
• Participate and support in internal and notified body audits and support audit finding closure for both quality and manufacturing

Other key short-term projects:

• Responsible for investigating a 5-day reportable event requiring Remedial/Field Action
• Non US/EU Global complaint and adverse event management improvements and harmonization to ensure global regulatory timeliness and compliance
• Key Role in CAPA for prevention of late regulatory submissions to global health authorities due to lack of procedure, training, and information traceability

Confidential, Buena Park, CAMar 2009-Jul 2009
Intern - Compliance and Coordinator

• Participate in board meetings for IRB approval of clinical research protocols
• Review protocols for FDA and OHRP regulations and identify non-compliance issues for need of an expedited review or full board review
• Evaluate IRB applications for completeness and conformance to IRB application rules and FDA Regulations. Alert IRB Manager, Chair and Medical Director to protocol issues that may need closer review
• Maintain IRB files and databases. Generate IRB statistical reports based on databases
• Working with the IRB manager, MD, Chair and other staff members to prepare initial accreditation documents, site visit preparation, and annual accreditation reports to maintain accreditation

Confidential, Mumbai, India Jul 2006-Dec 2006
(Affiliations: Cleveland Clinic, Ohio, USA; Only hospital in India accredited by ISO 9001:2000, NIAHO, JCI)
Biomedical Engineer

• Installed, calibrated, serviced and tested standard hospital equipment
• Trained the hospital staff for efficient usage of hospital equipment
• Documented service reports, calibration reports, planned preventive maintenance

Confidential, Mumbai, India Mar 2005-Jul 2006
Repair and Assembling Technician

• Assisting customers in selection of customized computer system components and assembling them
• Resolving computer related hardware and software issues.

CURRICULUM BASED PROJECTS

510(k) Notification

Documented a 510(k) for an unclassified medical device according to the FDA requirements

Cochlear Implant Labeling

Summarized the approaches to label a cochlear implant in the EU and concerns associated with it

Case Study: Complaint Handling

Prepared a report on the investigation of the root cause of a complaint to determine its reportability and to determine corrective and preventive actions

Process FMEA

Conducted Risk Analysis using process FMEA for implantation procedure of an aortic stent, involving quantifying and prioritizing risks and developing a mitigation strategy

Standard Operating Procedure

Prepared a sample Standard Operating Procedure for manufacturing a medical device along with Operating Procedure, Manufacturing Flowchart, Controlled Material List, Raw Material Specs, Equipment/Tool Registry & Specs & Final Device Specs, all according to QSR (21 CFR 820)

Instrument Design

Developed and tested a unique Ultrasonic Hand Torch as an aid to the visually impaired.

Design Input Document

Drafted a Design Input Document for a class III implantable medical device

EDUCATION

Master of Science, Biomedical Engineering
(Specialization in Quality Systems and Regulatory Affairs)
Bachelor of Engineering, Biomedical Engineering

Relevant Courses: Quality Systems and Standards, Application of Risk Management Tools and Techniques, Regulation of Medical Devices and Diagnostics, Global Regulation of Medical Products, Biomedical Instrumentation, Human Anatomy and Physiology, Basic Workshop Practice, Respiratory and Cardiovascular Physiology, Transducers in Biomedical Instrumentation, Electronic Circuit Analysis and Design, Analog Integrated Circuits and Applications.

TECHNICAL SKILLS

Technical software: PSPICE, Multisim, MiniTab, MATLAB, MS Word, MS Excel, MS PowerPoint, MS Access, MS Visio, Adobe Acrobat

PROFESSIONAL CERTIFICATIONS AND MEMBERSHIPS

• Member of ASQ
• CQE expected September 2011