Quality Assurance Medical Devices

NAME:A.V.RAMANA

Contact No.:+91-984*******;E-Mail:**********@*****.***

Address: Plot#17/1, Road#25, VN Colony, Kukatpalli, Hyderabad-500072,INDIA

I am BE(Electronics and Communication)andM.Tech(IEM) and have 32 years of experience in Quality Function(QC, Quality assurance of Defence, Railway electronics projects, Medical Devices, PCB Assembly Quality and testing of electronics components,Modules and PCB Assemblies; and Supplier Quality and evaluation, In-coming Quality(electronic components, mech & sheet metal, Plastic and rubber parts), In-process Quality, WIRING HARNESS QUALITY,Process audits, Supplier Audits, Out-going Quality, ISO certification & Implementation of QMS, Trainings, Customer Support&Satisfaction., SAP-QM

I have a good knowledge in medical devices Quality,SMT PCB Assembly and ESD requirements, Calibration,MRB & ECN approvals. Also I have a good knowledge and implemented Quality Management Systems(ISO-9001:2015) and ISO13485 and 21CFR,Part820 of USFDA previously worked as MR

Job Profile:

1. Present Job: Head of Quality at Majik Medical solutions povt ltd., Hydereabad, I am responsible for Quality of Catheter components, and updating QMS Procedures as per ISO13485:2016 and as per 21CFR, Part820 of US FDA. Responsible for AUDITS, MRM, Chamge management, process improvements, customer relationship management, complaints handling, CAPA, Drawings approval etc.

2.HEAD-Quality(Fans and Motors), Tibrewala electromech Pvt Ltd., Hyderabad:(Sept.2021 to Jan 2023)Responsible for Complete Quality operations(right from incoming inspection, supplier audit, process audit, Final QC, Customer engagement, PPAP, New product approval, ECN issue etc.

3.Self Employed :(Sept.,2020 to August,2021): worked as Consultant for manufacturing & Quality of PCB Assembly mfg. company.

4.DGM-Quality: HBL Power systems ltd, Hyderabad(August,2014 to Sept.2020)

I have been working in Quality control and assurance processes and testing of Defence Electronics project(DCH Project: Rs.280 crores), ESS,QT & ET and inprocess testing/inspection, PCB Assembly inspection(SMT & Through hole), final inspection and Third party inspection by SQAE(L). Followed JSS-55555 Standards for DCH Project and aware of MIL standards, IPC-A-610 etc. Aware of AS9100 and implemented ISO-9001:2015 for defence and Rail electronics.

I was In-charge for Railway Electronics Systems(IPS, TCAS),Solar Pump Inverter Quality and Supplier Audits, and customer complaints analysis and resolution of complaints.

Implemented Kaizen, 5S,8D.

I have a very good experience in PCB Assembly including SMT process, wave soldering process, ESD management practices and inspection as per IPC-A-610D.I have been dealing with 3rdParty Inspection agencies SQAE(L),RDSO, SSQAG.

At HBL, I have implemented SAP-QM, Cpk and COPQ for Railway, PCB Assembly, Solar Electronics divisions.

5.DGM-Operations, ANALOGIC CONTROLSINDIA LTD., HYDERABAD.(April,2013 to April,2014)

Looked after Manufacturing operations, Production, materials planning, Project management, customer interaction,scheduling of,DRDO, BDL,ECIL projects,

6.SENIOR MANAGER-QA& MR(3-years, 2-months), at OPTO CIRCUITS INDIA LTD., VISAKHAPATNAM,AP,INDIA.(17-02-2010 to 3-05-2013); Medical devices manufacturing

Opto Circuits India Ltd.(Vizag SEZ) & OPTO CARDIAC CARE LTD.(OCCL) :

Good hands on work experience on the following:Medical devices mfg.: Incharge of QC & MR:

Patient Monitoring systems and Pulseoxy meters, ECG Machines and AED Trainers, Digital Thermometers:

liaison between departments and makes independent decisions to insure adherence to quality procedures at OCIL(Patient Monitors) & OCCL(Burdick ECG Machines)

Developed and implemented quality procedures and champions Quality Activities.

Developed and maintained monthly Quality report.

Responsible for assuring out going Quality of Patient Monitors.

Established metrics reporting, and analyzes results of in-process activities.

Prepared Monthly reports for management and presents status to management and customer as required.

tracks responses to internal CARs and supplier CARS/8D Reports.

As a Management Representative(MR) implemented ISO-13485 & ISO9001:2008 for TWO Companies and Maintaining quality standards .

Review & Control of Quality Manual, Quality Procedures, WI’s, Drawings, ECR/ECN/CO’s and all other Quality System Documents.

Conducting Internal Audits and MRM’s.

Incharge of Quality from Incoming materials to Final Despatch and customer complaints analysis.

7. Solar Semiconductor Pvt ltd.(May2008 to Feb.2010) :HEAD-QUALITY& MR: Responsibilities: over all QA incharge for PV Modules. Managing A WORK FORCE(Engineers, operators, Supervisors,Managers).

Solar cells inspection, Solar Modules inspection, Tabbing, Stringing, Layup,inspection,Lamination inspection,Electrical

testing, Framing inspection,Final Module inspection.

Implemented Quality Tools such as SPC, Bar charts,Quality Circles, CAPA, 8-D Techniques,5-S Implementation,, calculating

yield rates, Reliability analysis, etc.; Implemented ISO-9001:2008 and,Internal audits, worked as MR

8. ECIL RAPISCAN LTD(October-1995 to May-2008)Jt.GM & MR: ( Joint Venture company of : ECIL(Govt. of India) and OSI SYSTEMS Inc. USA) Engaged in manufacturing of advanced X-Ray Baggage Inspection Systems), Designation: Jt.GM-Quality

Responsibilities:

Inward inspection of, PCB's, PCB assemblies, Electronic components, Mechanical frames, etc.

Process improvements in the PCB assembly manufacturing line, soldering line.

19" rack for computers assembly. Idler rollers, Machine Mechanical assembly, Fabricated parts

* Testing of XBIS Machines, at ECIL Factory ; Hyderabad.

* Trouble shooting of XBIS PCB's, such as Image processor PCB, analog PCB's

* Following Safety rules & Regulations(National & International)

*implemented ISO-9001:2000 in the company and its branches.

* As a 'MANAGEMENT REPRESENTATIVE', I have implemented ISO-9001:2000,in our

company and branches and got it certified by 'DNV'.

* Final inspection testing of X-Ray Baggage Inspection systems, all Metal Detectors.

* conducting Internal Auditing, Management Review Meeting and Training to the Engineers.

Software skills – SAP, Windows Operating System – XP, MS Office, Good comunication and power point presentation skills.

MAINTENANCE Dept.(ECIL RAPISCAN LTD): additional responsibility: Installation and Commissioning; Servicing,AMC of X-RAY BAGGAGE INSPECTION SYSTEMS(XBIS) ; Explosive Detectors(IonScan-400), Metal Detectors.

* Trouble shooting of XBIS PCB's, such as Image processor PCB, analog PCB's.

Training to the Service Engineers Training to the Customers

* Preventive Maintenances and Break-down Maintenance to the XBIS Machines, * Annual Maintenance Contracts

* order booking of Preventive Maintenance Contracts, * Good communication skills and fluent in English.

* Analysis of customer complaints, * Commercial activities, MIS etc.

* good knowledge about the Sales & Marketing

9. HBC Flextech ltd(Feb-1994 to October-1995):Asst.Manager-Quality:

Responsibilities: QC In-charge of Flexible PCB’s: Inward inspection, In-process inspection of PCB's, testing of PCB’s, assemblies, Soldering Process,

Fnal Inspection

10. APIC LTD(January-1992 to February-1994): QC ENGINEER: AQUAGUARD WATER PURIFIERS &

Filters(UV based):APIC LTD.(Subsidiary of Eureka Forbes Ltd.Manufacturer of AQUAGAURD Water Purifiers) ;

Responsibilities:

a). Inward inspection of, PCB's, testing of PCB assemmblies, Final inspection of units,inspection of Electronic components,Photoresistor assembly, Unit wiring, UV Lamps, Chokes, Transformers, Solenoid valves(Eaton).

e). received MERIT AWARD for my meritorious services.

11. Sulakshana circuits ltd(April-1989 to January-1992): Responsibilities: Asst.Manager-QC: PCB’s Mfg:worked right from the Project stage,later established the Quality dept and worked in-charge of the Quality Dept. of bare PCB’s manufacturing, PCB’s

bare board testing.

12. Compact Circuits Ltd(Dec-1988 to March1989), Kashipur, UP: QC ENGINEER(PCB’s Mfg):

Responsibilities: worked right from the Project stage,and worked in the Quality dept. : PCB’s inspection, PCB’s bare board testing

Achievements :

Water Purifiers(AQUAGUARD): Recived MERIT AWARD from APIC LTD. (Subsidiary of Eureka Forbes Ltd.)

Implemented ISO-9001:2000 in the present company and got it certified by DNV, and Maintained till 2008.

Implementation of ERP for present company.

Achieved good customer satisfaction; As a 'MANAGEMENT REPRESENTATIVE', I have implemented ISO-9001:2000,in our

company and branches and got it certified by 'DNV'.

Received TWICE “Performance based Incentive DEPOSIT” from ECIL-RAPISCAN LTD. Project Implementation & Completion

Completion of DCH Project of INDIAN ARMY(Rs.280 Crores)

Educational Qualifications:

B.E(Electronics & Communication)) with FIRST CLASS 61.5%; University :NAGARJUNA UNIVERSITY(A.P)

PROJECT on RADAR: I have done Project work on RADAR(during my B.E Course): study of wse-74 S Band RADAN & Measurement of its Parameters.

M.Tech(Industrial Engg. & Management),JNTUCollege of Engg, JNTU, Hyderabad(Govt.University Campus College) passed in FIRST CLASS with DISTINCTION.

Special subjects: Materials Management, Production &Operations Management, Simulation & Modeling, Reliability Engg. &

Management, Supply Chain Management, TQM, Financial Management, Process Control, Computer Applications, MIS etc

M.Tech PROJECT:IMPROVEMENT OF PERFORMANCE SPECIFICATIONS OF X-RAY BAGGAGE INSPECTION SYSTEM(XBIS) AND ERGONOMICS OF THE MACHINE

(I have done this project at ECIL(Govt. of India PSU), Hyderabad-62, AP, INDIA.)

Diploma :DIPLOMA in MANAGEMENT fromIndira Gandhi National Open University(IGNOU)

Computer Courses: SAP-MM, JAVA based ERP, Languages : FORTRAN-IV; C; JAVA;Operating Systems : WINDOWS-XP, WINDOWS-8

TRAINING : Trained on XBIS Machines QA/QC, Mfg & Maintenance at RAPISCAN SYSTEMS, MALAYSIA.

SEMINARS AND TRAINING PROGRAMS attended:

Certified Internal Auditor for ISO 9001, ISO 13485(by UL India)

Leader ship, and team building training by Solar Semiconductor, Hyderabad.

Familiar with IPC A 610 D standards.

Trained on ‘Risk Management’ of medical devices at OPTO CIRCUITS INDIA LTD & by UL India.

Trained on ‘Testing & QUALITY’ of X-Ray Baggage Inspection Systems at RAPISCAN SYSTEMS, MALAYSIA.

Personal details :

Nationality : Indian

Languages : Telugu, English, Hindi

Martial Status: Married

A.V.RAMANA

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