Quality Management
Resume:
SAJID SALAT
acgcdl@r.postjobfree.com
PROFESSIONAL SUMMARY
An astute professional with over 18 years of experience in Document Control, Quality Management System,
Process Improvement, Project Management, Product Lifecycle Management, New Product Development and
Introduction, with strong communication, leadership, relationship management, coordination, analytical and
problem-solving skills.
Deft in handling various modules of Agile PLM, Master Control for Process, viz. Change Management,
Configuration Management, Part & Document Management, Administration, Workflows, Supplier Integration
and integration with Oracle.
Highly skilled in Functionality Testing, Integration Testing, System testing, User Interface Testing as well as
defect and test environment management, planning walkthroughs and reviews.
Resourceful in creation and execution of test cases, test scenarios, bug documentation / tracking; creation of
project documents like test plans, schedules, release notes & defect tracking reports for PLM software.
ACHIEVEMENTS AND ACCOMPLISHMENTS
Agile PLM Implementation – Agile 8.5, 9.0, 9.2.25, 9.3.1 (PC, PQM, PG&C modules)
Master Control Configuration – Version 10
Continuous Improvement – Launched "It's About Time" continuous improvement initiative
Quality Management Systems Management – Developed Lotus Notes databases for the Quality groups to
streamline the reporting of the quality related issues, CAR, Deviations, Stop Ship, RMA, Quality Incident
Reports, Calibration Logs, Quality Systems Training, Quality and Documentation Systems Forum
Education and Training – Developed and maintain employee training program, Quality Systems and
Configuration Management best practices
Awards - “Outstanding Performance” in the areas of Team Work, Customer Orientation, Quality, Team
Work and Problem Solving and Customer Champion” at Logitech, Inc.
AREAS OF EXPERTISE
Lean Six Sigma Black Belt, Oracle Agile PLM, Oracle ERP, Oracle Content Management, Domino Lotus
Notes, Quality Management Systems, including Corrective & Preventive Action (CAPA), Internal Quality
Audits (QMS), Continuous Improvement (CIs) and Facilitation, ISO 9001, 13485, 14971.
PROFESSIONAL EXPERIENCE
Thermo Fisher Scientific, Fremont- CA (2012-
Present)
Thermo Fisher Scientific Inc. is the world leader in serving science to make the world healthier, cleaner and
safer. With revenues of $20 billion, and over 55,000 employees serving customers within pharmaceutical and
biotech companies, hospitals and clinical diagnostic labs, universities, research institutions and government
agencies, as well as in environmental and process control industries offering a unique combination of
innovative technologies, convenient purchasing options and a single solution for laboratory operations
management.
DOCUMENT CONTROL MANAGER
(2012- Present)
Manage Document Control, Packaging & Labeling / Graphics and Training departments for FDA-regulated
and ISO certified company.
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.
• Collaborate with cross-functional departments to ensure timely implementation of change requests
and change orders
• Coordinate all activities related to migration from Agile PLM to Master Control
• Streamline company Document Control process to ensure Quality System documents (DMR, DHR,
Records, Lab Notebooks etc.) are controlled, released and available per regulatory requirements.
• Manage training system to ensure employee records are current per training plans to the current
version of the tasks
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• Assist Regulatory Affairs to maintain Design History, Technical files, external standards and 510 k
submission
• Assist Quality Management Systems during FDA inspections, ISO, customer audits and other third
party Quality System evaluation
• Manage graphics and labeling group. Implemented E-PI program resulting in $700K savings
• Manage CLP/GHS and UDI implementation program
• Manage off-site storage. Re-negotiate off-site storage to bring the cost down by 15%
• Ensure records retention policy is enforced and documents. Ensure documents are reviewed and
archived and/or disposed per company policy
• Manage translation of the labels, insert and datasheet per regulatory requirements.
• Maintain $1.5M translation budget. Review and negotiate with vendors saving 22% on translation
costs.
• Streamline the Quality Management System processes
• Introduced and provide monthly Quality matrix via dashboard
Logitech Inc., Fremont- CA (1995- 2012)
Focused on innovation and quality, Logitech designs personal peripherals to help people enjoy a better
experience with the digital world. With a market cap of about $2 Billion and over 9,000 employees, Logitech
offers hardware and software enhanced digital navigation, music and video entertainment, gaming, social
networking, audio and video communication over the Internet, video security and home-entertainment control
GLOBAL QUALITY CHANGE MANAGEMENT MANAGER (2011- 2012)
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 (2010- 2011)
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 SYSTEMS MANAGER (2004- 2010)
Set up Documentation Systems for AMR region by managing a team of Quality and Documentation Systems
teams with offices in the US, Canada, Europe and Asia Pacific to process Changes reducing the total cycle
time from 7days to 3.6 days. Migrated DMS from Lotus Notes to Agile PLM to accommodate the product
portfolio growth from 77 to 600 product lines.
• Defined and established the processing and controlled storage of change requests, procedures,
work instructions, specifications, protocols, reports, document templates, drawings, artwork, software,
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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 post-production.
• Implemented Agile 8.5 to replace a custom-based DMS tool developed in Lotus Notes into Agile
utilizing Cadence Project Management techniques. Responsible to upgrade to Product Service and
Improvement (PSI) and Product Quality (PQM) modules to Agile PLM 9.2.2.5.
• Used Oracle 11i to reproduce engineering/manufacturing documentation, drawings, bills of
materials (BOMs), parts lists specifications and engineering change orders (ECOs).
• Coordinated document control services with engineering, planning, production, supply chain, and
marketing functions. Liaison with New Product Introduction (NPI) and Package Development teams in
developing specifications, scheduling product launch and availability in various regions and on web.
• Teamed up with various committees on as needed basis in-order to clearly define documentation
requirements, and subsequently prepare and distribute according to schedule.
• Managed Product Identification Coding / Serialization System to assign a unique product code
to trace the product history and guarantee support.
• Established document Record Retention System to ensure adherence to customer, legal, and
business requirements.
• Responsible for the strategic development and implementation of cost-effective training and
support solutions that are designed to provide improved productivity, streamlined operations, and faster
access to critical information.
SR. QUALITY SYSTEMS ENGINEER (1998- 2004)
Introduced automated Quality Management System for better visibility, ease of management and faster
response time for enhanced customer satisfaction. Designed, developed and maintained Quality related
Lotus Notes database for easy access to document RMAs, Rework, APIs, etc.
• Mana
ged the transition to ISO 9001:2000 Certification.
• Managed ISO certificate, coordinated Management Review and Surveillance Audits.
Coordinated with executives/ functional managers to develop and implement process improvements to
achieve maximum levels of quality.
• Designed and managed Corrective and Preventive Action (CAPA), Deviation and
Stop/Resume Ship programs. Trained end users for proper resolution of any process or product related
nonconformities to ensure on time shipments with established standards of safety, quality, reliability,
performance and functionality.
• Participated in Supplier surveys and developed scorecards for supplier qualification.
• Developed an Return Material Authorization System to document process from initiation,
classification, disposal, and replacement to resell
• Developed Defect Code Assignment System to identify and segregate functional failures,
mechanical failures and cosmetic flaws that do not meet established acceptability criteria.
PROCESS ENGINEER (DELEGATE MANAGEMENT REPRESENTATIVE) (1995- 1998)
Introduced automated Quality Management System for better visibility, ease of management and faster
response time for enhanced customer satisfaction. Designed, developed and maintained Quality related
Lotus Notes database for easy access to document RMAs, Rework, APIs, etc.
• Mana
ged the transition to ISO 9001:2000 Certification.
• Managed ISO certificate, coordinated Management Review and Surveillance Audits.
Coordinated with executives/ functional managers to develop and implement process improvements to
achieve maximum levels of quality.
• Designed and managed Corrective and Preventive Action (CAPA), Deviation and
Stop/Resume Ship programs. Trained end users for proper resolution of any process or product related
nonconformities to ensure on time shipments with established standards of safety, quality, reliability,
performance and functionality.
• Participated in Supplier surveys and developed scorecards for supplier qualification.
• Developed an Return Material Authorization System to document process from initiation,
classification, disposal, and replacement to resell
• Developed Defect Code Assignment System to identify and segregate functional failures,
mechanical failures and cosmetic flaws that do not meet established acceptability criteria.
EDUCATION
Master of Science
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Industrial & Systems Engineering, California State University, San Jose, California, USA
Post Graduate Diploma (PGD) in Business Administration,
Bachelor of Engineering (BE) in Mechanical Engineering
Certified Quality Auditor (CQA) and IRCA Certified Lead Assessor (CLA) of Quality Systems (1994,
2000 and 2008)
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