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Quality Medical

Location:
Dix Hills, New York, United States
Salary:
$ 165k
Posted:
May 20, 2017

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BAMAN PATTANAYAK

* ******* ***** ***# (631) ***-**** (H)

Dix Hills (516) ***-**** (cell)

New York 11746 e-mail: ac0ejs@r.postjobfree.com

SUMMARY

Senior Quality and Regulatory professional experienced in high tech and medical device manufacturing industries. Progressive responsibilities in all areas of Quality Systems in the implementation of TQM, SPC, Six- Sigma, re-engineering, Continuous Improvement, Quality function deployment, implementation of FDA-GMP or QSR, ISO-9001, EN-46001, ISO 13485, EC Directives for CE marking on products, Clinical trial and Product approval from the FDA,

and all sorts of regulatory compliance with PMA/IDE, FDA, EC MDD and Canadian Medical Device Regulation.

SIGNIFICANT ACCOMPLISHMENTS

As a Director of QA, successfully implemented ISO 9001 quality system. Achieved ISO 9001 certification and CE marking on precision motion technology products per EC machinery directive. Implemented SPC and Six- Sigma. Increased on time delivery of products from 40% to 70% and reduced warranty field return by 40%.

As a Director of QA and RA, successfully achieved ISO 9001, EN 46001/ ISO 13485 and EC medical device directive certification for CE marking on products. Obtained 510k approval from FDA for three new and two substantially changed Radiography and Mammography products and four PC based virtual imaging software medical devices. Monitored clinical study for one new mammography product and three virtual imaging products Per IDE regulation.

As a QA & RA Manager, successfully achieved ISO-9001, EN 46001/ISO13485 and EC medical device directive certification for CE mark on ultrasonic dental and X-ray products on time and within budget. Obtained 510k approval for three new dental products. Monitored clinical studies for two new products involving new technology per IDE regulation.

As a Section Head of Quality Assurance established a TQM program and implemented Statistical Process Control, significantly reduced direct and indirect costs for all major Defense programs.

EXPERIENCE

As a Quality and Regulatory Consultant and also as a regular employee established and maintained ISO 9001, ISO 13485, FDA 21 CFR Part 820 Quality System Regulation and ISO 17025 quality system, FDA 510(k) submission, approval and CE marking approval from EU Competent authority and all regulatory compliance in the following companies of Long Island, NY.

1.Quantum Medical Imaging, Bohemia, NY

2.Viatronix Inc, Stony Brook, NY

3.Rotronics Instrument Inc, Hauppauge, NY

4. Trex Medical Corporation, Bennett Division, Coppaigue, NY

5.Dentsply International, Cavitron Division, LI City, NY

6.Rockwell Automation, Anorad Division, Hauppauge, NY

7.Measurement Specialists, Cosense Division, Hauppauge, NY

8.Olympus America Inc, Medical System Division, NY

Air Techniques Inc. Melville, NY 3/2016 to 5/2016

Dental Products

Established FDA Unique Device Identification Regulation as a Regulatory /Quality Consultant and create or update of Quality System Procedures to comply with ISO 13485, CE Mark to EUMDD and FDA QSR.

Rortonic Instruments Inc., Hauppauge, NY 11/2012 to 4/28/2017

Manufacturing and Calibration of Thermodynamic Instruments

Established and maintaining ISO 9001 and ISO 17025 Quality Systems as a Consultant for manufacturing and calibration of Relative Humidity and Temperature measuring systems in a manufacturing environment for medical, pharmaceutical and food industries. My contract will end on April 28, 2017.

Viatronix Inc, Stony Brook, NY 11/2002 to 07/2016

Medical Devices Manufacturer: Regulatory and Quality Consultant

Established and maintained Quality and Regulatory system in compliance with FDA QSR, ISO 9001, ISO 13485 and EC medical device directive for this start up medical device company. Prepare and submit to the FDA 510k notifications for product approval by the FDA and EC technical file for CE marking of products.

Developed and maintained Quality Manual, Standard Operating Procedures, design control procedures, test and validation protocol in compliance with Quality and Regulatory requirements. Supervised product inspection and testing activities in compliance with protocols. Perform audits and monitored FDA audit and ISO 13485 audit implement CAPA. Established FDA UDI regulation.

OLYMPUS AMERICA INC, Center Valley, PA 3/2003 to 10/2012

Medical Systems Group

A six billion dollar corporation involved in manufacture, sales and service of medical devices for colonoscopy, bronchoscopy, laproscopy, biopsy, various surgical products, sterilization equipment and application software related to medical devices.

Sr. Director of Regulatory Affairs and Quality Assurance reporting to the Vice President RA/QA

Responsible for establishing policies and procedures that ensures the quality of medical devices hardware and software products to meet ISO 13485, FDA QSR, EU Medical Device Directive, Canadian Medical Device Regulation and CE marking requirements. Providing planned periodic appraisals and audit to Executive Management for their review and action. Involve in FDA GMP audit, ISO 13485 audit and recall implementation. Managing RA/QA department consisting of two RA/QA Managers, three Technical writers and ten QA Engineers, One QA auditor and one Admin Assistant most efficiently.

Supporting the goal of continuous improvements through the development of specific policies and procedures and setting long range quality plans to include establishing quality cost objectives and customer satisfaction targets

Overseeing, reviewing and assisting the development of Standard Operating Procedures

Managing submittal of 510(k), CE Technical file for CE mark authorization from Notified Body and labeling process including promotional materials. Overseeing through a group of technical writers the development of user manual, Technical bulletins, Installation, configuration and set up manual and service manual

Establishing policies and procedures to comply with HIPAA regulations and ISO 17799 international standard for security protection

Providing Quality assessment, regulatory requirements and due diligence for global business venture for marketing and distribution of medical devices in EU countries, Australia and New Zealand.

Establishing OSHA compliance, compliance with blood bourne pathogen, establishing HBV program and operating room protocol training

Assisting the Corporate Compliance department with environmental regulation and serving as in-house advisor for UL test requirements on products to comply with IEC standards for safety and EMI/EMC.

Establishing and maintaining CAPA system for hardware and software medical devices

Monitor control of hardware and software development subcontractors or vendors.

DEL Global Technologies, Valhalla, NY 10595 1/2003 to 3/2003

A hundred million dollar corporation involved in manufacturing of high voltage power supplies for airport security bomb scanners, high voltage radiological and industrial X-ray machines, monoblocks for X-ray medical devices etc. in an electromechanical manufacturing environment.

Director of Quality Assurance reported to the Vice President of Operations

Responsible to set up a quality system to meet ISO 9001, develop quality manual and procedures

Managed quality assurance and quality control of high voltage power supplies, power equipment, monoblock for X-ray devices through a Quality Manager

Managed repair and service of power supplies and power equipment and monoblocks for X-Ray device through a supervisor.

Involved in one FDA-GMP audit and resolved issues raised on FDA 483

VIATRONIX INCORPORATED, Stony Brook, NY 6/2001 to 10/2002

A start up company involved in innovation, development, production, sales and service of PC based virtual imaging systems for colon, aorta, abdomen, aneurysms, heart and systems for other organs of human body to provide radiologists with improved diagnostic modality and inexpensive screening capability to detect suspected cancerous polyps, tumors or other defects like blockage, fracture etc . This is a new PC based three- dimensional volume rendering system technology developed by the State University of New York at Stony Brook after ten years of research.

Director of Quality Assurance and Regulatory Affairs reported to the President and CEO

Established and maintained Quality and Regulatory system in compliance with FDA QSR, ISO 9001, ISO 13485 and EC medical device directive for this start up medical device company. Prepare and submit to the FDA 510k notifications for product approval by the FDA and EC technical file for CE marking of products.

Developed and maintained Quality Manual, Standard Operating Procedures, design control procedures, test and validation protocol in compliance with Quality and Regulatory requirements. Supervised product inspection and testing activities in compliance with protocols. Participated in design reviews for new or substantially changed products. Developed, established and monitored change control, document control and software configuration control processes. Trained employees on procedures and processes.

Actively participated and managed Internal Quality audit, GMP audit and ISO 9001 certification/ surveillance audits and implement corrective and preventive actions to resolve FDA 483 issues and Notified Body or internal audit issues. Provided support as a complaint officer to resolve customer issues or complaints.

Managed and supervised QA/RA activities and three QA engineers, one Tech Writer and QA Secretary

Involved in registration and licensing of medical devices in foreign countries and also dealing with export regulation

ANORAD CORPORATION, (A Rockwell Automation Business), Hauppauge, NY 8/1999 –4/2001

Involved in design, manufacture, sales and service of leading edge precision motion control system for automotive, semiconductor, and medical equipment industries (MRI machines) in an Electro-mechanical manufacturing environment of stages, gantries, linear motors, controllers, computers, PCBs, cables, harnesses and application software products.

Director of Quality Assurance, reported to the President

Corporate leader for all quality initiatives in four divisions. Managed fourteen QA and QC staff including a QC Manger

Implemented a quality system management to ISO 9001 requirements. Established a continuous improvement process.

Quality Assurance of Laser and OEM products for medical equipment. Conducted and oversaw employee training program, equipment calibration, incoming, in -process and final inspection and testing of products.

Implemented SPC and Six sigma techniques for monitoring processes. Implemented vendor rating and supplier certification program.

Set budgets, allocated resources and worked with manufacturing, Engineering, R&D and Technical services to

coordinate activities and set policies..

Participated in design approval review, coordinated technology transfer from R&D to Production departments, monitored hardware and software validation/verification.

TREX MEDICAL CORPORATION-BENNETT DIVISION, Copiague, NY 10/1995- 8/1999

A hundred million dollar Division of Thermo-Electron Corporation-Medical Device Manufacturing Company. Involved in design manufacture, sales and service of Radiography and Mammography machines, spot digital and full field digital

Mammography systems, needle biopsy, stereo tactic biopsy systems and their application software etc.

Director of Quality Assurance and Regulatory Affairs, reported to the President

Managed staff of twenty one including a QC Manger and QC Supervisor responsible for QC, QA and RA activities.

Responsible for Quality System Management to ISO 9001 and EN46001 standards, FDA-GMP/QSR and accountable for all regulatory compliance viz. 510k notification, initial report, annual report, medwatch report etc. Also responsible for export regulation compliance and foreign registration of products.

Developed and maintained a quality manual and documented quality assurance appraisal SOP’s conforming to product specification and regulatory standard of the FDA/QSR, code of federal regulation and EC Medical Device Directive.

Managed incoming, in-process and final inspections, auditing, certifications, product engineering, change control

and release documentation.

Prepared and set budget and budgetary compliance, allocated resources and work with Operations, Engineering, R&D and Technical Service to resolve quality issues, customer complaints and product recalls.

Involved in product engineering, release design and documentation, new product launch activities, coordinated new product regulatory testing by UL and EMI/EMC test laboratories for CE marking.

Coordinated and monitored clinical study/evaluation at three hospitals in accordance with IDE regulations for product PMA/510K approval by the FDA.

DENTSPLY INTERNATIONAL, CAVITRON EQUIPMENT DIV., Long Island City, NY 6/1992- 10/1995

A sixty million dollar Medical/Dental manufacturing company involved in design, manufacture, and service of ultrasonic dental Equipment, dental hand pieces and inserts, Suction pumps, dental X-ray, root canal inserts, amalgam, dental crown, etc

Quality Assurance and Regulatory Affairs Manager, reported to the Director of Q.A/RA.

Managed QA department of six staff involved in QA systems/activities related to design, manufacturing and Marketing of medical/dental products in conformance to FDA/GMP, UK/GMP (Green Book). ISO 9001, EN 46001 Quality Standards, EC Medical Directive and CE Marking.

Prepared/updated QA manual, SOPs, process control instruction, developed test protocol, monitored product quality, process reengineering for continuous improvement, 510k submission, regulatory PMA approvals for new product in domestic and international market.

Developed and implemented a complaint handling system to efficiently resolve customer issues.

Monitored two clinical studies of new equipment at Dental Medical Schools in accordance with the FDA/IDE requirements and annex-X of EC Medical Device Directive.

HARRIS CORPORATION, GOVERNMENT SUPPORT SYSTEM DIVISION, Syosset, NY 7/1983- 6/1992

A three billion dollar corporation involved in automatic test equipment manufacturing for US Navy and Air Force, RF and Microwave instruments.

QA Engineer, Sr. QA Engineer, Lead QA Engineer and QA Section Head- Reported to QA Manager.

Responsible for QA project management, program supervision, supplier evaluation, rating and certification and quality evaluation of hardware and software products for highly complex state-of –the- art computerized automatic test equipment, RF and Microwave test instruments.

Reviewed proposal, contract, and Military standards and specifications for quality planning, participated design review, material review board and change control board., Prepared QA budget and monitored budget. Prepared quality trend reports and charts

Hands on experience in continuous improvement, TQM, SPC and supervision of quality assurance system to MIL Q- 9858 standards.

VIKING ENERGY CORPORATION, Pittsburgh, PA 5/1982-6/1983

Quality Engineer, reported to QA Manager

Responsible for vendor survey, source inspection and quality control to NQA-I of nuclear and commercial components. Prepared quality reports, and interfaced with customer representatives for resolving quality issues.

Studied codes, standards and specifications of ASTM, ASME, AWS, CMAA, NEMA OHSA and other military standards for developing quality plan and procedures.

PERSONAL

U.S. Citizen

EDUCATION

Pursued Ph.D. (Industrial Engineering), Polytechnic University, Brooklyn, NY.

Completed course requirement (with GPA 3.9) and passed the Ph.D. qualifying test.

MS (Software Engineering Management), Long Island University, Greenvale, NY (GPA 3.9)

BE (Mechanical Engineering) from Univ. of Calcutta, PG Diploma in SQC from Indian Statistical Institute, Calcutta

MBA (Industrial Management) University of Calcutta, India.

Ranked first in MBA.

CERTIFICATION & TRAINING

ASQ Certified Quality Engineer and Certified lead Auditor for ISO-9001/ISO-13485

Special training in Computer Aided QA, Software QA, Machine Tool Technology, Machine Wave Soldering, Production Management, Leadership management training, ISO 9001, EN 46001, ISO 13485, EC Medical Directive, Canadian Device Regulation and FDA- GMP/QSR, HIPAA Security regulation and implementation, FDA product approval, 510(k) preparation etc.

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PROFESSIONAL MEMBERSHIP

American Society for Quality (ASQ) and Regulatory Assurance Professional Society (RAPS)

COMPUTER SKILLS

Microsoft Word, Excel, Outlook, Access, Power point and Project



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