Management Quality

A D I T Y A GU P T A

* * * * ** COSA AVENUE FREMONT, CA 9 4 5 3 6

PHONE : 510- 3 6 4 - 2 3 0 0 • E -MA I L : ADI TYANGUPTA@YAHOO . COM SUMMARY

Implementation & maintenance of ISO 9001 at multiple locations, ISO 13485 program including audits & certification

Proven track record in planning & implementation of new products/programs within budgeted cost, time and quality at all stages from NPI, prototyping, manufacturing, and end of life (EOL)

Extensive experience in customer and supplier management

Successfully managing direct reports in cross-functional environments PROFESSIONAL EXPERIENCE

AAyuja Inc. – Newark, CA Apr 2016 – Present

- Corporate management of company activities including finance reporting, recruiting and wage structuring

- Developing and implementing program management policies / processes at corporate level for implementation across organization (e.g. formal status reporting, quality updates)

- Developing metrics for measuring performance quality and productivity / efficiency

- Handling performance appraisals / reviews within organization

Thermo Fisher Scientific – Sunnyvale, CA 2007 – Mar 2016

- Audit organization’s quality procedures for ISO-9001 and ISO 13485 implementation as an internal auditor.

- Develop internal audit schedule, including mapping 21CFR part 820 (QSR) sections to ISO 9001-2008, communicate with process owners, and perform audits. Follow-up with auditee for closure of critical issues

- Manage external audit for ISO 9001–2008 & ISO 13485 certification, surveillance and re-certification

- Host and follow-up on customer quality audits on-site as well as complete customer surveys/questionnaires

- Prepare Quality Manual and common procedures (SOP) for organization to ISO 9001 certification

- Prepare management review documents for ISO 9001 & ISO 13485

- Prepare procedure for disposition of non-conforming products across manufacturing, assembly & test phases

- Review, analyze, and dispose non-conforming products (MRB activities)

- Prepare procedures (SOP) for vendor evaluation/ assessment and vendor rating system

- Conduct vendor/supplier quality audits for vendor capability, delivery, and managing supplier performance

- Prepare procedures for calibration of instruments used in product development, production, and inspection

- Maintain calibration systems across organization

- Carryout failure analysis, root cause, corrective and preventive action (CAPA), and engage on continuous process improvements around manufacturing & product performance

- Maintain organization’s Quality Management System (QMS), periodic procedure (SOP) reviews and updates

- Carryout product manufacturing audits for conformance of procedures, manufacturing practices, and testing methodologies.

- Develop labels for specific products and maintain quality records / batch records for same.

- Collect and maintain Key Performance Indicators (KPIs) and matrices in Oracle and SAP environment.

- Implemented 5 S program in operation areas and engineering labs

- Trained and mentored 2 teams on Continuous Process Improvement thru 8 D step PPI methodology using various SPC tools including control charts, Pareto chart, run charts, Fishbone, histograms etc. and PDCA.

- Identified critical FMEA issues – implemented processes to reduce failure rate from 6.8% to less than 1%

Galgon Industries – Fremont, CA 1996 - 2007

- Manage ISO 9001 surveillance, upgrade from ISO 9001-1994 to ISO 9001-2000, and re-certify audits with external auditors; close non-conformance reports and obtain certification to ISO 9001-2000 as management representative.

- Performed gap-analysis between existing and mandated systems to fit ISO 9001 requirements; developed procedures (SOP) across various departments/functions for all identified gaps

- Prepare Quality Manual and common procedures for organization to ISO 9001 certification

- Prepare management review documents for ISO 9001 as management representative

- Prepared and implemented quality plans for two product lines, including voice of process for reporting and reducing DPM

- Trained 300 employees in ISO 9001 implementation

- Supervised quality assurance departments across organization

- Implemented four grass root projects product lifecycle, i.e. from conception through prototyping, new product introduction (NPI), BOM structuring in Oracle environment, DFM/DFA analysis, ECO implementation, improvements, Manufacturing Assembly Instructions, manufacturing & assembly layout, testing, shipping, and material storage

- Implemented 3 new product lines, including capacity planning and analysis for different customers

- Developed process flow for single part flow manufacturing/lean manufacturing and suitable Kanban system

- Developed plant layout, process & material flow system for assembly – coordinated equipment installation for product line, including capital costing/resourcing (45,000 sq. ft. production area)

Tata Consulting Engineers & VAM Organic – India Until 1996

- Managed projects from feasibility stage through management approval to implementation. Managed engineering consultants, architects, suppliers and contractors

- Estimated costs for polyester fiber and yarn plants – applied value engineering/management techniques and reduced capital investment by $15 million in 8 months (10% capital cost reduction)

- Managed engineering, purchasing, and project site activities for $50 million cement manufacturing project, including material transport system, utilizing project management expertise (work breakdown structure (wbs), network PERT/CPM)

- Prepared specifications, evaluated supplier proposals, and recommended purchase of piping system, refrigeration, and air-conditioning systems for power and chemical plants QUALIFICATIONS

Completed Lead Auditor training of quality system audit to ISO-9001-2008 and ISO 9001-2015

Completed Lead Auditor training of quality system audit to ISO-13485

Completed Practical Process Improvement Facilitator & Process Champion training

Completed course on “Managing Supplier Performance – Measurement, certification, quality improvement”

Presented a paper on Value Engineering at a National Conference EDUCATION

Masters in Business Administration (MBA)

Masters in Mechanical Engineering (M.S. ME)

Bachelor in Mechanical Engineering (B.S. ME)

XLRI, Jamshedpur

Indian Institute of Technology (IIT), Roorkee

Indian Institute of Technology (IIT), Roorkee

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