Built ISO 9001 and IATF 16949 QMS from scratch within first two years of employment.Acted as Multi site quality managerChampioned change in legacy thought process.Instituted processes to ensure clarity, and act as a catalyst to provide a platform for timely decision making.

Contract medical Device manufacturing Quality Manager.Hosted FDA audit. Acted as ISO Management Representative, host and manage all quality audits from registrars and customers.Present and Prepare Yearly Quality Budgetary requirements.Maintains and improves product quality by completing product, company, system, compliance, and surveillance audits; investigating customer complaints.Maintain, publish and document internal metrics and conduct Management review.Involved and managed complete Validation life cycle.Developed Electronic Records and Electronic Signatures assessment documents by performing part 11 assessment to the components involved in maintenance of electronic records, signatures, audit trail in accordance with 21 CFR part 11 regulation.Wrote Software Operational (OQ) and Performance Qualification (PQ) test scripts (for medical devices software management) and wrote Validation Summary Report (VSR).Validated Enterprise Labeling information system (ELIS) that was designed to process labeling for packaging of medical devices.Led efforts to enhance customer experience with policy deployment and process enhancements.Generated Risk Traceability Matrix (RTM), Gap Analysis, and Remediation plans for validation projectsResponsible for communicating complaint responses or other Quality concerns with other departments. Oversee validation (IQ/OQ/PQ) program and write Master Validation Plans. Supplier quality audits and management.Maintain and manage ISO 9001, 14001, 13485, FDA 21 CFR 820 and TS 16949 certification( Tier 2).Monitor,Prepare and report Cost of quality, KPI's.Directly responsible for ISO 9000:TS16949 Quality Management Systems and AIAG Core Tools; i.e. APQP, FMEA, MSA, PPAP, SPC.

NuVasive is a medical device company focusing on the design and development of products and procedures for minimally invasive spine surgery.Worked in coordination with ISO and Regulatory Quality Compliance department to review non conformances of Spinal Implants and surgical instruments. Worked cross functionally Regulatory, Product Development, and Operations to ensure all non conformity/issues are successfully resolved.Involved in various functionalities of calibration, functional testing (Data recording and SAP)and Material Review Board (For CAPA and SCR’s) for medical devices such as implants and instrumentsDemonstrated applied knowledge of: International medical device and FDA regulations;Monitored root cause and investigations and CAPA (through vendor follow up)are performed in timely manner as documented in Non Conforming Material Report (NCMR)

Worked as a lab and teaching assistant for Geometric Dimensioning and tolerancing (GD&T)• Troubleshot all equipment malfunctions with attention to details• Experience using computer software & hardware; both PC & Macintosh• Enforcing all lab policies

•Achieved internal ISO 9001 compliance and document structure within targeted period. Procedures and work instructions implementation/modification through out the processes determining total number of operations and corresponding documentationSupported the program manager to implement the ISO 9001 quality management system (QMS)Standardized work instructions throughout the production areaMajor contributor in creating the documentation and control structure within the companyPrepared schedule and assignments to achieve an ISO compliant quality management system in second quarter of 2009

Made valid recommendation to Implement new product flow line by conducting root-cause analysis and recommending corrective action (CAPA), complying with FDA QSR and cGMP regulations, to modify manufacturing set up that resulted in cost saving ( $1500-2000 per annum) through removal of frequent tubing replacement. Assisted in running AUTOCLAVE cycle for disposables and stainless steel equipments.Assisted in Laboratory sampling for flu vaccines in ISO CLASS 1 cleanroom environment.Conducted and documented (MS Word) the outcome of root cause analysis, based on CAPA, on equipment failure and made recommendations to improve equipment functionality as per FDA QSRExecuted equipment Installation Qualification (IQ) and Operational Qualification (OQ) validation protocol as per FDA QSRInterfaced with suppliers and vendors for quotations, repair and replacement of equipments including check valves, impellers etc. and new equipment procurement

Minimized waste/scrap utilizing lean manufacturing through identification of process improvement opportunities, which resulted in cost saving Led a team of supervisors and technicians for process optimization, through QIT (Quality Improvement Team), which effected in an increment of production capacity New Product Development Worked on Lean Manufacturing initative involving Value stream mapping based production system. Scheduled production planning, inspected performance analysis of the production line and measured critical parameters of the product to report non-conformance. Performed Process Capability analysis (CpK), analyzed data using control chartsParticipated in process, product audits, and vendor auditsPerformed Root cause analysis and Corrective Action resulting in the permanent removal of the fundamental problem and improved the customer index. Assisted in creation of PPAP documentationMaintained inspection procedures, quality assurance plans, test procedures and process flow documentation to ensure ISO compliance.