Ajay Joshi
Fremont
Summary
A highly analytical and results-driven professional with proven experience implementing Quality management systems in numerous industries from tiny startups to large corporations. A team player with a “customer first” attitude and extensive knowledge of Lean manufacturing principles and a demonstrated history of delivering outstanding results in all areas of operations, including outsourced manufacturing. Can add value to any organization by: Utilizing vast industry experience to develop Quality Strategy and implement Quality systems to increase efficiency and decrease operating costs Leveraging knowledge of regulatory compliances such as ISO 9000, ISO 13485, cGMP, TL 9000, SOC2, and ISO 14001 to achieve operational improvements Continuously searching for ways to streamline processes, improve quality, and enhance customer satisfaction
Overview
27
27
years of professional experience
Work History
Sr. Director of Quality
TeraPore technologies
South San Francisco
10.2021 - Current
- Architect of the quality infrastructure for a cutting-edge nanotechnology firm. Responsible for building a professional Quality Culture and 'Quality DNA' from the ground up.
- QMS Implementation: Developed QMS system from scratch and spearheaded the selection and enterprise-wide rollout of the QMS system in a Biotech nanofiltration company, digitizing QMS processes.
- Founded the Quarterly Quality Council Review to align executive leadership on quality objectives and KPIs.
- New Product Development (NPDI): Developed and enforced Design Control procedures, providing training for all staff to ensure quality integration throughout the product development lifecycle.
- ISO 9001:2015 Certification: Directed the end-to-end certification process, successfully achieving ISO compliance in September 2024 with zero non-conformances.
- Successfully managed and coordinated the preparation for high-stakes customer audits.
- Risk Management: Led comprehensive FMEA sessions across all departments, creating RPN summaries to prioritize and mitigate high-risk safety and failure modes.
- Supplier Quality Excellence: Standardized the supplier lifecycle by implementing a robust SCAR (Supplier Corrective Action Request) process and conducting technical desk audits for critical BOM components.
- Spearheaded the preparation and delivery of critical quality documentation requested by key strategic customers, ensuring full compliance with their specific vendor requirements.
- Actively monitored and integrated customer expectations into the internal quality framework, specifically regarding viral filtration (VF) specific quality regulations and commercial standards.
- A Biotechnology company specializing in advanced nanofiltration membrane systems used in biopharmaceutical production
Director of Quality
Lahlouh, Inc.
Burlingame
03.2013 - 09.2021
- Responsible for the overall Quality strategy of the company, document control and management, customer interaction for qualifications, and corrective and preventive action (CAPA). Established customer satisfaction surveys and feedback process. Manage all internal and supplier quality and regulatory audits. Monitor and improve key supply chain KPIs.
- A printing, packaging, mailing, and marketing fulfillment company
- Developed and ensured execution of a quality plan that improved on-time delivery (OTD) and reduced scrap and customer returns by >90%.
- Established quality metrics and dashboard and drive continuous improvement activities.
- Designed processes towards 21 CFR820 and 21 CR Part 11 audits.
- Implemented supplier qualification process and evaluation metrics.
- Chair quality management reviews, including customer feedback, mfg. quality, cost, and CAPA.
- Partnered with IT to develop and implement homegrown QMS system.
QA Manager
AMAX Information Technologies
Fremont
09.2012 - 02.2013
- Led Quality group, including product manufacturing, and supplier. Responsible for handling requirements of more than ten customers, including escalations. Managed 20 direct reports.
- A privately-held technology company that specializes in providing tailored application solutions
- Championed problem solving and root cause analysis activities with suppliers to eliminate issue recurrence.
- Implemented Quality metrics and Quality improvement activities.
- Led ISO 14001 certification.
Senior Director of Quality
Café Press
San Mateo
07.2004 - 06.2012
- Developed Quality strategy and led Quality group in three different locations. Managed Quality programs for internal manufacturing and multiple outsourced contract manufacturers, including qualification. Oversaw numerous initiatives to enhance overall business operations, including product development, software creation, manufacturing, supply chain management, and customer satisfaction. Performed supplier qualification and supplier audits. Managed 100 direct and indirect reports.
- American online retailer of stock and user-customized on-demand products
- Promoted through a series of positions with increasing responsibilities (Quality Manager → Senior Quality Manager → Director of Quality → Senior Director of Quality).
- Established a production-Quality system involving rapidly changing manufacturing processes that resulted in 15% scrap reduction, 14% customer satisfaction increase, and 3% return rate improvement.
- Instituted and applied Quality metrics at the manufacturing partner, leading to continual progress, including improved adherence to customer service-level agreements (SLAs) for delivery from 50% to 97% and improved outgoing defect rate at the manufacturing partner by 50%.
- Led new product introduction and contributed $7M in annual revenue by spearheading the introduction of approximately 60 new products from selection to release to manufacturing.
- Created Customer Quality Council to listen to the voice of the customer and fulfilled another role managing a customer service group with suppliers in Manila and Mississippi.
- Administered a $2M annual operating budget and significantly enhanced operations: Cut abandoned call rate from 15% to 3%, slashed average wait time from 90 to 30 seconds and average hold time from 450 to 280 seconds, and boosted customer satisfaction score from 70% to 93%.
- Selected to lead project transferring production from the facility in CA to plant in KY, including implementation of the new automated conveyor system; completed the project on time within an ambitious three-month time frame.
QA Manager
Sorrento Networks/LuxN
Sunnyvale
08.2000 - 07.2004
- Established Quality systems for an optical networking company. Led Quality group and implemented processes based on Six Sigma for new products through manufacturing at the supplier. Steered supplier Quality functions, including overseeing qualification procedures and audits. Fulfilled additional role as head of document control and led change management activities. Managed three direct reports.
- The United Kingdom’s only manufacturer of fiber networking equipment
- Played a vital role in the product requirements document (PRD) review process and developed product Quality plans.
- Increased automated test yield at the supplier from 66% to 99%.
- Generated functional test improvement from 33% to 96%.
- Slashed final systems test defects from 14 defects/system to 0.13 defects/system.
- Successfully led ISO 9000:2000 implementation and began the application process for TL 9000 Rev. 3.0.
- Conducted quality business reviews (QBRs) with the key suppliers. Established ship to stock program for printed circuit board assembly (PCBA) and sheet metal chassis suppliers.
Engineering Program Manager
Solectron Corp
Milpitas
06.1999 - 08.2000
- Managed integration of customer manufacturing into Solectron, ensuring successful transition, including electronic data transfer, technology implementation, product tracking, manufacturing process development, and transitioning production operations between facilities.
- First electronics manufacturing company for original equipment manufacturers
- Instituted numerous process improvements that increased functional test yield from 4% to 75%.
- Guided production initiatives with as many as 90 product variances, handling manufacturing transition from customer to Solectron.
- Managed seamless transfer of complex manufacturing processes between multiple plants.
Education
Master of Science (MS) - Industrial Engineering
University of Oklahoma
Norman, OKBachelor of Science (BS) - Mechanical Engineering
University of Pune
Pune, IndiaSkills
- Quality management systems development
- Strategic quality planning
- Customer satisfaction
- Corrective and preventive action (CAPA)
- Training and development
- Quality metrics and audits
- ISO 9001 and ISO 13485 compliance
- Supplier quality management
- Risk management strategies
- Electronic assembly techniques
- Good manufacturing practices (GMP)
- Failure mode and effects analysis (FMEA)
- Root cause analysis
- Continuous process improvement
- Design and document control
- New product development initiatives (NPDI)
- Cross-functional leadership
- Microsoft Office Suite proficiency
- Data analysis and reporting tools
- Statistical process control (SPC)
- Enterprise resource planning (ERP) systems
- Agile project management methodologies
- Change management processes
- Performance improvement metrics
- Business process reengineering strategies
- Customer satisfaction enhancements
- Information and records management practices
Knowledge Of Other Business Cultures
- India
- Philippines
- Singapore
- Canada
Languages Fluent
English
Core Competences
Microsoft Office Suite, SAP, Agile, Statistical, SQL, Zoom, ERP, Document Control, Audits, Change Management, Customer Satisfaction Improvements, Attention To Detail, Interpersonal Communication, Leadership, Team Building
Industry Insights
- Biotechnology
- Computer hardware
- Computer networking
- Computer software
- Consumer electronics
- Consumer goods
- Consumer services
- Design
- Electrical/electronic manufacturing
- Executive management
- Industrial automation
- Information technology and services
- Mechanical or industrial engineering
- Medical devices
- Outsourcing/offshoring
- Products
- Pharmaceuticals
- Program development
Professional Development
- ISO 13485 Lead Auditor Training
- FDA cGMP for Medical Devices Training, 21 CFR Part 211
Timeline
Sr. Director of Quality
TeraPore technologies
10.2021 - Current
Director of Quality
Lahlouh, Inc.
03.2013 - 09.2021
QA Manager
AMAX Information Technologies
09.2012 - 02.2013
Senior Director of Quality
Café Press
07.2004 - 06.2012
QA Manager
Sorrento Networks/LuxN
08.2000 - 07.2004
Engineering Program Manager
Solectron Corp
06.1999 - 08.2000
Master of Science (MS) - Industrial Engineering
University of Oklahoma
Bachelor of Science (BS) - Mechanical Engineering
University of Pune