Quality, Regulatory, FDA Inspections, Validation, Management

Results-driven, self motivated and creative Leader in the Medical Device, Life Sciences industry with excellent planning skills, the ability to identify with internal and external customers provide them with the right products and solutions on time.

Skills

Implementation and Management of 21 CFR Part 820 Quality Management System, 21 CFR Part 11, CE Technical File, IEC63204, DHR, DHF, DMR, Lot Identification and Traceability, MDR review, Compliance, FDA Audit/Inspection, Close 483 observations, Supplier/Vendor Audit, Internal Audit, Design Control, SDLC, Process Improvement, Change Control, Remediation, labeling, 510(k) submissions and Regulatory Affairs for Class II products (7 years)

Verification and Validation, Defect Management, Requirements writing and management, Design Control, SDLC, 21 CFR Part 820 Quality Management System, 21 CFR Part 11, ISO 13485, ISO 14971, IEC60601, Gap Analysis, Project Plans, Reports, CAPA, Nonconformance, FMEA, Complaints investigations and root cause analysis (15+ years)

IQ/OQ/PQ, Disaster recovery planning and verification, Server Qualification (4+ Years)

LIMS, ELN (Electronic Lab Notebook) (2+ years)

Product development (15+ Years)

Management and Leadership Experience (10+ years)

Class II Device 510(k) Submissions, 510(k) responses (7 years, 6 submissions)

Direct FDA Inspection experience and remediation (7 years, 4 inspections)

Management representative in four FDA inspections: Remediated and closed out minor 483 observations in two inspections, no 483’s in two.

EXPERIENCE

BL Healthcare, Inc, Director Quality Assurance 4/2005 – Present

Responsible for the Implementation and Management of 21 CFR Part 820 Quality Management System, 21 CFR Part 11, CE Mark Technical File, IEC63204, DHR, DHF, DMR, Lot Identification and Traceability, MDR review, Compliance, FDA Audit/Inspection, Close 483 observations, Supplier/Vendor Audit, Internal Audit, Design Control, SDLC, Process Improvement, Change Control, Remediation, labeling, 510(k) submissions and Regulatory Affairs for Class II products.

Experience includes Verification and Validation, Defect Management, Requirements writing and management, Design Control, SDLC, 21 CFR Part 820 Quality Management System, 21 CFR Part 11, HIPAA, ISO 13485, ISO 14971, IEC60601, Gap Analysis, Project Plans, Reports, CAPA, Nonconformance, FMEA, Complaints investigations and root cause analysis.

Management representative in FDA inspections in 3 FDA audits (one with no 483 observations and the others with minor observations). Remediated 483 observations identified during the inspections. Obtained ODI certification (Open Development Initiative - cellular), IEC60601-1-1 and 60601-1-2 certification for the devices.

Responsible for all areas of Quality including QMS, Design Control, Complaints, CAPA, Supplier qualification, Purchasing and Production controls, Incoming and outgoing materials, complaints, root cause analysis, defect management, project management and release

Quareg, Inc 1/2006 – 12/2011

Client: Boston Scientific, Software QA Consultant 5/2008 – 12/2010

Worked on a medical power supply project through the requirements, software development, risk analysis and verification processes through FDA approval. Created software development plan, tests, documented and mitigated software risks, executed system verification tests. Worked with co-developer/vendor to ensure that the SDLC deliverables were in compliance with the corporate and vendor SOPs, reviewed software and hardware verification and validation plans, results and approved project deliverables, participated in design and code reviews, tests, results of the software verification, and reports. Performed gap analysis for IEC62304 to ensure compliance with the standard.

Client: Infosys Technologies Ltd, India, Medical Device Quality Consultant 9/2007 – 4/2008

Help create and tailor corporate quality processes, procedures and templates to comply with FDA requirements. Help with customer audit preparation, audit and presentations. Trained team on the FDA QSR and implemented processes for medical device software validation.

Client: Millennium Pharmaceuticals, Inc., Validation Consultant 1/2006 – 8/2007

Wrote plans, tests and reports for Synthematix eNotebook (ELN) validation. Validation included software validation and chain of command process for retrieving data from offsite vendor and verification of disaster recovery. Met with internal customers to understand the work flow for use of Laboratory Information Systems for non GLP studies and provided a customized Watson LIMS solution that would fit their needs. Wrote plans, tests and validated Watson LIMS application. Analyzed and created work flows and processes for using Watson as a central data repository for non GLP studies.

Client: Virtify, Inc., Quality Consultant 1/2006 - 6/2007

Created and implemented the Quality Management System with policy and procedures for Virtify. Conducted training for employees on the Quality policy and procedures. Prepared for audits and represented company in vendor audits. Reviewed project documents and DHF for completeness and compliance. Reviewed IT disaster recovery plans and security plans for completeness and testability.

Abbott Laboratories, Software Verification & Validation Manager 3/2001 – 12/2004

• Set goals for 5 direct reports and 3 contractors, performance evaluations, hiring and training resources to satisfy project needs, mentoring, estimating resource requirements and participating in budget planning. Managed multi-disciplinary project teams, estimated work, provided updates to senior management and tracked schedule to always on-time completion of deliverables.

• Managed testing, verification and validation activities including creation and execution of plans and protocols for Hospital glucose meters, data management system and non-product software including DOORS, PVCS Version Manager and PVCS Tracker. Created IQ/OQ and PQ protocols for validation. Performed 21CFRPart11 Gap Assessment for software and tools.

• Created a site-wide procedure and form for documentation and approval of corrections to verification and validation protocols during execution saving several weeks per V&V execution by minimizing nonconformances.

• Developed a script based automated test system to simulate meter use, perform assays with objective evidence for performing over 60,000 tests on the meter before product release realizing a savings of over 3000 hours of testing time. The automated tests also stressed the database and Web User Interface revealing defects that would not normally be found.

• ROI analysis on Home Data Management automated testing showed savings of over 300 person days by the use of Winrunner and Ghost software.

• Led engineering investigations to determined root cause on returned products to identify mechanical, electrical and software issues and performed trend analysis to identify critical issues. Implemented Corrective and Preventive actions to resolve the field issues. Design changes resulted in resolution of over 70% of complaints. Closed out CAPAs pertaining to complaint investigation.

• As engineering representative, responsible for all engineering CAPAs, non conformances, defects and complaints from initiation to closure.

Alcon Summit Autonomous Inc, Project Manager/Developer 12/1999 – 1/2001

• Led a multi-disciplinary team of 12 team members on Denali 3.6 project. Project involved full product development including marketing, software development, customer support, Quality and Regulatory control and manufacturing. Released product on time.

• Created Product Development Operating plan, Project Initiation docs and schedule for the release with active team input. Designed and developed Prepare 2.0 software for pre-programming Lasik eye treatments to minimize errors and speed up processing. Managed V&V resources for testing deliverables, verification and validation.

Image Technologies Corporation, Software Engineer 1/1998 - 12/1999

• Responsible for hardware selection and full life cycle software development for TroView, a unique PC based endoscopic imaging system.

• Managed the software development through the full life cycle with delivery of a FDA approved final product.

• Trained customers on installation and use and created quick user guides for doctors and nurses.

Genus, Inc, Software Engineer 12/1995 - 1/1998

• Responsible for development, testing and release of software for the G1500, G1510 and G1520 Ion Implanter.

• Interacted with marketing and product support to determine customer requirements, documented software requirements, test procedures and released software.

Bio-Plexus, Inc, Software Engineer 4/1994 - 9/1995

• Key resource for the design, development, installation and debugging of new image processing algorithms, to enhance the efficiency of vision and motion control systems including x-ray vision.

• Improved the efficiency of automated needle assembly from 94% to 98%, by devising and programming a light control algorithm for compensation of product color variation and loss of bulb efficiency. Programmed GE Fanuc PLC using Ladder Logic.

Dapco Industries Inc Ridgefield, CT ,Internship 1/1993 - 4/1994

• Redesigned timing and control sequencing in PLM/51 and 8051 assembly for a 16-channel nondestructive ultrasonic pipe inspection system based on PLC inputs for start, end of test, and probe up/down to enable the appropriate channel for testing.

• Devised new host configurable, system independent distributed painting scheme to paint flaw type, channel ID and defect type based on masks downloaded from the PC. Wrote timer interrupt to calculate speed of moving pipe for accurate painting.

EDUCATION

5/1994 MS in Biological Engineering, University of Connecticut

7/1988 BS in Electronics and Instrumentation, R.V.C.E, Bangalore

5/2006 Online Graduate certificate in Entrepreneurship,

Boston University School of Management

Recognition:

Received recognition from large customer in Japan via email to the General Manager (Genus, Inc.) for software development and support. This was the first time anyone was recognized by this customer.

Abbott Laboratories

Recognized for creating the automated test system for simulating assays

Recognized for being the V&V subject matter expert during FDA inspection

Recognized for speeding up QA review process by creating standardized templates for Verification and Validation plans, tests and reports and gaining agreement on the process

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