1) Working on Bureau of Indian Standard Certification for ICU Ventilator Anesthesia Machine Workstation according to IS/ISO 808601:2:12:2020 & IS/ISO 808601:2:13:2022 (First time certification in India for the same).2) Internal factory quality affairs related to product & supplier audits.3) Active participation in developing & updating PPAP,PFD,PFMEA, Control Plans, Preparing Quality Plans, Inspection Plan, Test Procedures and Check list for in Process Inspection & ensuring the compliance.4) Developed and implemented a regional strategic vision and mission consistent with Corporate Objectives and industry-leading Quality, Regulatory, and Compliance performance requirements.5) Assembled a high performance team to assure effective and efficient execution of strategic vision.6) To initiate any amendments to Quality System, if required. 7) Coordinate with R&D Team for solutions with help of feedbacks.8) Quality control involves testing of units and determining if they are within the specifications for the final product. 9)The purpose of the testing is to determine any needs for corrective actions in the manufacturing process. 10) Look after all Quality and testing responsibilities of Standard Operating Procedure with the help of samples of final products from the Production & ensure that all the procedures followed by him and his teams.11) Workplace team will check and inspect the Product for all the functional and operational working throughout with the Standard Operating Procedure as they have.12) To identify the training needs of personnel in the department and send the requirements, if any.13) To maintain and implement the Quality System in the department.14) Ensuring proper maintenance of QA equipment, jigs and fixtures.

Regulatory affairs Indian FDA (CDSCO), CE Self Certification, Brazil AN Visa, TGA Australia, ISO 13485 notified maintaining Quality Management System, facing audit, re issue of certificate on time, Updating management on all aspects before time in order to maintain state of the art working.(1) Internal factory quality affairs related to product & supplier audits.(2) Developing plans & protocols for process validation and ensuring timely execution.(3) Maintaining Quality systems, customer quality and calibration.(4) Active participation in developing & updating PPAP,PFD,PFMEA, Control Plans,(5) Preparing Quality Plans, Inspection Plan, Test Procedures and Check list for in Process Inspection & ensuring the compliance.(6) Complaint handling, Market reviews, Customer feedbacks and customer visits to improve the Quality of products.(7) Quality requisitions for procurement inputs to the management and commercial office for improvisation in purchase orders in terms of Quality.(8) Skill enhancement through training, team building and employee motivational activities.(9) Analyzing non-conformance and devising corrective / preventive actions in order to prevent the repetition of problem and minimizing rejection.(10) Work environment, Quality standard such as Safety,Cleanliness & Discipline..(11) Product life cycle till incerination studies, Clinical Evaluation Studies, Stability,Bio Burden, (12) Gamma radiation process verification.(13) Implementation of UID.(14) QMS implementation SOP, WI, Reports & Records.(15) Product release and certificate of analysis.(16) Driving continual improvement initiatives like Kaizen, small group activity to achieve optimum operational performance at lowest cost.(17) Formulating departmental objectives based on the annual business plan.

Key Results Areas:(1) Managing all function of QA deptt. including administration. (2) Control and distribution of all documents related to Quality functions.(3) Planning, co – ordination, controlling and monitoring all Quality activities.(4) Establishing necessary controls in Quality.(5) Approving corrective actions.(6) Annual budget preparation for Quality Deptt.(7) Support supply chain deptt. for new & existing product development.(8) Control of measuring and test equipment's.(9) Ensuring proper maintenance of QA equipment, jigs and fixtures.(10) Establishing inspection and testing procedures and quality plans.(11) Identifying and establishing statistical technique.(12) Review of nonconformity, and necessary corrective / preventive action. (13) Generating Vendor Rating on monthly basis for Quality Issues.(14) Associated MR for ISO 13485-2016/9001-2015/ICMED(15) Planning and execution of internal quality audit and management review.(16) Implementation of ZED Certification(17) QSR-21CFR 820–FDA Bio Medical Products., 5 S Systems, IPC-A-610D and RoHS compliance implementation.(18) Supplier audit system, documents, TME tooling, work placement mgmt. etc.conduct daily material review board (MRB) meeting and take “Go or No Go” decision based on quality and customer requirement of the product.(19) Conduct weekly 1 to1 meeting with subordinates for work status and quarterly performance review.(20) Customer and Third party inspection (TPI).

Key Results Areas:(1) Suppliers’ audits and suggestions for improvements.(2) Mould maintenance and up gradation as per plan.(3) Ensuring all process parameters of moulding are running as per the defined Procedure.(4) To analysis I.F.R & F.F.R(5) Process Monitoring / workout for critical problems in Production, analysis CAPA.(6) MIS on daily, weekly & Monthly basis.(7) ISO documentation & Implementation.(8) Internal auditing of other departments(9) Close co ordination with customer during the clearance (PDI) of the material at out going stage.(10) Coordinating Quality circles at shop floor.(11) Ensuring all test in lab are conducted as per IS: 3854 & IS: 1293 requirement.(12) Initiation & Implementation of PPAP at Supplier end.(13) Leading, motivating and training the employees to improve their operational efficiency.(14) Ensure that gauges, instruments are calibrated.

Key Results Areas:(1) Conducting audits on line and appropriate feedback for CAPA.(2) To compile the various defects and inspection activities in all line of the module and preparation of MIS.(3) Internal audits of various departments in order to ensure the quality norms are being followed properly.(4) Plan the activities of the given shift as per quality plan to ensure least rejection and optimum productivity.(5) Maintenance and calibration of testing machines.(6) To check whether given quality system is followed.(7) Testing of various Electro-mechanical parameters with the help of latest equipment's like CD & DVD CATS and PROMETEOUS MT146.

Key Results Areas:(1) Testing of various electromechanical parameters with the help of latest equipment's like DVD- CATS, PROMETEOUS, DUC10 Sony Make, ONO-SOKKI & ETA-RT.(2) Monitoring of quality standards as per ISO 9001.(3) Field Failure analysis and meeting customer regarding the quality and performance of the product.(4) Attending Seminars and meetings for demonstrating routine as well as occasional problem related to the product and process and finding their solutions for the continuous profit of the organization.(5) Prepare and analysis the shift gradation report. Comparative studies of the product through graphical analysis of various properties.(6) Interacting with Line & Moulding Incharge to time base so that quality standards maintained.

(1) Incoming Quality Control: Inspection of Machined, Fabricated, Moulding, Painting,Electronics & Electrical parts.(2) Development of Jigs and Fixtures.(3) Ensure corrective actions from suppliers for non-confirming parts for improvements in future lots.(4) Suppliers’ audits and suggesting for improvements.(5) Control of Quality records and formats.(6) Inspection and Approval of Samples for additions of new suppliers (FAIR)(7) Internal Bin Audit.