Manager, Document Control
ThermoFisher
Total years of experience :33 years, 3 Months
Manage Document Control, Packaging & Labeling / Graphics and Training departments.
Responsible for compliance with Federal, State and local regulations pertaining to training, FDA/GMP/QSR, ISO9001/ISO13485/CMDR/CE and associated regulatory agencies through effective management of internal audit functions.
• Implement Master Control to replace Agile
• Manage training programs
• Assist with Regulatory Affairs with RA team
• Assist with Quality Management Systems during FDA inspections, Notified Body, customer audits and other third party Quality System evaluation
• Implement E-PI saving $1.2 million
• Re-negotiate off-site storage to bring the cost down by 15%
• Manage $1.5M translation budge. Re-negotiate with third party vendor translation, saving 22% cost savings
• Streamline the Quality Management System processes
• Introduced monthly dashboard
Responsible for Agile 9.3.1 Implementation of PC and PQM modules to utilize the new feature introduced with the upgrade and reduce cost of maintenance by switching from Solaris to Linux Servers resulting in 30% increased efficiency. Also, introduced single-sign-on (SSO) and eliminated Digital Certificates with the introduction of secure Proxy servers for external users.
• Provide customers with direction and recommendations on the best practice offered with Agile 9.3.1 upgrade with hands on training, leading in workshops and brainstorming sessions to develop customer requirements.
• Develop PLM functional architecture strategies, instance strategies and manage data migration efforts using Cadence Project Management methodologies to perform according to the solution design with built in security as per roles matrix.
• As subject matter expert, provide end-user support, and resolve incidents with Agile PLM using HP QC bug logging tool.
• Developed Product Hub to have complete product details from various systems to a central location including the product hierarchy, lifecycle, warranty, product launch date by region, country of sale, regulatory requirements, product dimensions.
• Primary liaison between supply chain, customer support, launch project management teams and IT for new feature enhancement requests in Agile PLM.
CONTINUOUS PROCESS IMPROVEMENT MANAGER (2011- 2012)
Responsible for increasing Continuous Improvement Awareness making improvements became an organic part of employee’s work by conducting seminars, work group sessions, blogs and emails to review current processes, identify MUDAs, implement and monitor changes using PDCA to make them cheaper, better and faster with a target saving of $4.5 Million.
• Plan, launch, evangelize and facilitate "It's About Time" company-wide continuous improvement program.
• Facilitate cross-functional project teams to continually improve quality, cost, and cycle time of business processes.
• Document, analyze and continually improve business processes in collaboration with process owners.
• Introduced “iGrafx” for process mapping.
- Documentation Management System
Successfully Set up and Streamline the Document Control department. Manage Quality and Documentation Systems teams with offices in the US, Canada, Europe and Asia Pacific.
Define and Establish the processing and controlled storage of change requests, procedures, work instructions, specifications, protocols, reports, document templates, drawings, artwork, software, Bill of Materials, electronic and hardcopy archives, logbooks, and external standards in Business Planning and Control System (BPCS) environment through all stages of the Product Life Cycle (PLC), proto, pre and postproduction.
Implement Agile 8.5 to replace a custom-based DMS tool developed in Lotus Notes. Successfully upgraded to 9.0 and 9.2.2 versions with Product Service and Improvement (PSI) and Product Governance and Compliance (PG&C) modules.
Use Oracle 11i to reproduce engineering/ manufacturing documentation, such as drawings, bills of materials, parts lists specifications and engineering change orders.
Coordinate with engineering, production, and marketing functions in providing document control services and liaison with New Product Introduction (NPI) and Package Development teams in developing specifications
Ensure that documentation and production projects meet established quality standards, budgets, and deadlines.
Team up with various committees on as needed basis in-order to clearly define documentation requirements, and subsequently prepare and distribute according to schedule.
· Product Identification Coding / Serialization System
Manage the process to assign unique identifying strings used for product and warranty tracking.
· Record Retention System
Establish a cost effective records retention process to ensure adherence to customer, legal, and business requirements.
• Transition and Maintenance of ISO Certification
Successfully led the transition of world’s largest peripheral company to ISO 9001:2000 Certification. Manage activities related to maintaining ISO certificate, coordinate Management Review and Surveillance Audits.
• Corrective and Preventive Action System
Developed a tool for CA / PA system to eliminate the cause of nonconformity in order to prevent recurrence. The tool documents the resolution of process, product or policy nonconformities, from initiation, through investigation and planning, and finally to implementation and closure.
• Deviation Authorization System
Developed a DA system to allow deviating from standard defined business practices, documented procedures, or product specifications with valid reason, to allow product shipments on time / as per schedule.
• Incoming Quality Control / First Article reporting System
Established an IQC and FAI reporting tools to assure only high quality product are produced and shipped.
• Stop Resume Shipment System
Developed SS/RS system to ensure that only products that pass the established standards of safety, quality, reliability, performance and functionality reach the customers
• Return Material Authorization System
Developed an RMA tool to document process from initiation, classification, disposal, and replacement to resell
• Defect Code Assignment System
Developed a Defect Coding process to identify and segregate functional failures, mechanical failures and cosmetic flaws that do not meet established acceptability criteria.
• ISO Certification
Managed activities related to maintaining ISO certificate, coordinate Management Review and Surveillance Audits
• Internal Quality Systems Audit System
As a Lead Assessor, established an IQSA system to access the effectiveness of company’s Quality System and its business management systems.
Developed a program to recruit, train, and certify auditors to help maintain ISO Certification for the company.
• Quality Systems Reporting System
Developed a monthly QSR to report on the health of the quality system using Deming’s PDCA principals.
• Quality Database design
Developed and modified CARs, Deviation, Stop Ship, FAIR, Rework, RMA, Calibration databases in Lotus Notes.
• Quality Systems Training
Developed a New Hire Training program to train new employees on basic company and department processes and to familiarize them with the company standard tools. Develop an easy mechanism to familiarize them with the use company standard tools.
• Continuous Improvement Program
Helped to develop a Quality Toolkit for Continuous Improvement Program to train Engineers on effectively solving problems.
• Member ERP implementation Team
Teamed up with super user to test the newly implemented ERP system and to provide feedback on Quality and Documentation Services modules.
Material Department
Setup and Managed a multi-million dollar Materials Department.
Purchasing Department
Teamed up with purchasing to establish Kan Ban system.
Material Review Board
Headed the MRB board to review and dispose off material/product not meeting established standard
Planning and Scheduling
Managed both Turnkey and Consignment kitting operations
Incoming Quality Control
Developed IQC/FPQ Standard for Acceptance Quality Level at incoming and final inspection to improve profitability. Trained QC inspectors to conduct daily audits, and to monitor and maintain records.
Production
Streamlined and improved process and workflow to enhance yield and reduce cost using JIT, SPC, and DOE techniques.
Involved in root cause analysis and problem solving. Manage release of new assemblies to production and train employees on new documentation, drawing and any ECO's.
Statistical Process Control
Applied SPC to monitor and control assembly process. Perform periodic Cpk studies.
Capital Equipment Acquisition
Teamed up in equipment procurement process from selection, evaluation, and recommendation to negotiation and delivery.
Equipment Calibration System
Developed a program for the calibration and maintenance of measuring equipment.
Process Documentation
Developed new manufacturing procedures for PCBA's, and implementation of the existing processes.
ISO 9000:1994 registration
Teamed up with the ISO program manager to assist in registration efforts.
Electrostatic Discharge
Successfully implemented ESD safety measures for the whole assembly shop.
Material Resource Planning
Developed mini MRP, MPS, and CRP dbase for material and product control. Hands on experience on Novell based MRP system.
As a Teaching Assistant, assisted in setting up the course work, conducted problem solving sessions and examination, graded papers and lab work. Administer and maintained Apple Macintosh and IBM PC Network.
Helped SJSU library to design an integrated Information System
As a Research Analyst, created an analytical model to recommend work center layouts and service flow patterns for the Department of Mental Health of California using computer assisted statistical tools. Performed workload and time utilization Time and Motion) study to optimize staffing requirements based on customer requirements.