DePuy Synthes is a Johnson & Johnson Company manufacturing various medical devices and implants specialized in the area of Orthopaedics, Trauma, Spine, surgical Power Tools and advanced Biomaterials.Working in the capacity of Quality Consultant, specific areas of action include :- Integral team member in MDSAP (Medical Device Single Audit Program).- Initiating continuous improvement to the Quality Systems- Ensuring compliance to relevant Quality standards and Regulatory requirements.- As site Non-conformance Coordinator responsible for managing deviations and ensuring their completeness in a timely manner in EtQ system.- Working in cross functional teams to assist in Manufacturing investigations, product Quality escalations and internal audit observations.- Working in collaboration with Non conformance stakeholders to support and train them as necessary to ensure effective closure of actions.- Subject Matter Expert (SME) for Non-Conformance handling process.- Data collection, preparation, organization and presentation for the review of QPR (Quality Progress Report) and QSMR (Quality System management review).

Worked in the capacity of a consultant to help the client on a key customer approval audit for process and product.Key responsibilities included:1. Process mapping, risk analysis, preparation of Standard Operating Procedures, work instructions.2. Imparting customised trainings at all levels.3. Carrying out internal audits and implementation of CAPA.

1. Responsible for the overall functioning of the plant including production, quality, purchasing, logistics and inventory process.2. Setting up of new product lines, yearly target setting and course correction.3. Ensuring timely deliveries, in adherence to set production and quality targets.4. Employee training and motivation.

1. Responsible for management of the quality division including incoming inspection, process control, final product control and supplier process.2. Management representative for ISO 9001:2000 and AS 9100 rev B3. Setting up of the complete Quality Management System to meet the requirements of the parent company at US and France.4. Design and define the Documentation Management System linking the highest level of Quality document - the Quality Manual to subsequent Standard Operating Procedures,work instructions and forms.4. Trained and experienced in problem solving using 7 QC tools, KANBAN and FIFO methods, CAPA, risk analysis.4. Certified internal auditor for ISO 9001, AS 9100 and supplier quality audits.

1. Understanding and filling of control charts and training the shop floor operators on the same.2. Process Capability Analysis and improvement.3. Trained and implemented 5S principles on the shop floor.4. Maintaining and highlighting the data metrics for the Quality division.5. Organised and imparted training to the shop floor operators on various aspects of Quality.