Fred Mclendon Email & Phone Number

Costa Mesa, Ca

Goleta, Ca

Manage and Oversee activities related to the purchase of material, material control, inventory control, shipping/receiving and stores functions for the Neurosurgery Division.

Orange County, California Area

• Extensive knowledge in medical device manufacturing and operations management. • Working knowledge of U.S. Food and Drug Administration (FDA) and international standards for medical devices, over-the-counter drugs and cosmetic products. • Very strong leadership skills and proven ability to positively motivate others.• Operations and Quality leadership experience in Class I, II and III medical device manufacturing.• Proven manufacturing and Quality management experience working in both domestic and international environments.• Proven track record of successfully shutting down, transferring and starting up manufacturing operations in Mexico, Asia and Puerto Rico.• Turnaround specialist highly regarded for improving results of underachieving assets through optimizing resources and motivating people to perform at their highest level.

Costa Mesa, Ca

Expert Consultant in operations, quality and regulatory including product/process transfer to contract manufacturers, inventory systems, ISO 9000 certification and regulatory compliance. Recent clients include Pretty Woman Inc., HealthTouch Solution and Spirit Avionics.

Aliso Viejo, Ca

Oversaw and directed all quality assurance and regulatory activities for new product development, for U.S. and Asian contract manufacturers and company’s Mexico “maquiladora” operation. Recruited, developed and managed QA/QC and Regulatory staff in U.S. and Mexico.• Led transfer of product design and process technology from Mexico operation to Asia suppliers resulting in a 40% cost savings.• Implemented manufacturing changes which resulted in savings of over $250,000 annually.• Led manufacturing teams in implementiing Lean/Six Sigma as a practical approach.• Implemented quality system requirements and changes to support evolving regulations and international standards (FDA, Canadian and EU).• Served as company’s primary contact with FDA and international regulatory agencies.• Teamed with supply chain group in assessing Chinese manufacturing facilities thereby ensuring quality standards and compliance levels were maintained.• Served twice as acting Plant Manager for Mexico operation (400+ employees).

Birmingham, Al

Assumed newly created position to direct joint marketing program with pharmaceutical companies.• Developed technical training programs for 60+ direct sales reps to support sales growth in strategic geographic areas.• Grew sales in clinical research area by 25%.• Developed synergistic relationships with pharmaceutical companies and reference laboratories which resulted in a 15% increase in sales.

Birmingham, Al

Recruited to establish and manage operations during initial start-up. • Grew a small start-up lab producing 18 tests per day to a full-scale production operation with 50 employees producing 1,000+ tests per day. • Reduced cost per test by 20% and increased output by 50% through developing and implementing semi-automated test equipment.

Costa Mesa, Ca

Directed all manufacturing and engineering functions for production of fiber optic and electronic lighting systems. Managed team of six managers. Recruited to lead turn-around of production output.• Developed and implemented a manufacturing system that took R & D process from pilot to full production, while organizing the manufacturing facility for optimal output.• Designed experiments for improving a chemical manufacturing process and implemented process controls to maintain optimum performance, resulting in a 25% improvement in the product’s light transmission capabilities.• Applied lean manufacturing principles in reorganizing work teams, workflow, production cycles and quality standards, leading to a 50% reduction in manufacturing lead-time and a 12% drop in the standard cost of goods.• Created tracking metrics to reduce WIP, allowing Marketing to more accurately project delivery of high volume products. • Negotiated new contracts / pricing that led to lower raw materials expenses in a $5 million annual budget.

Azusa, Ca

Hired to turn around under-achieving materials and manufacturing operations at 2 plants with 100+ people.• Developed and executed the strategic plan for moving manufacturing and distribution operations from California to Puerto Rico and Boston without any downtime or missed shipments. • Managed expansion of Puerto Rico facility, including new construction and manufacturing process improvements, to meet 50% increase in production.• Led engineering and production teams in establishing assembly and production operations for Optical Mapping equipment used for eye surgery.• Managed the transition of a foldable intraocular lens from concept to commercial production.• Developed production metrics and implemented new processes which improved on-time shipments from 74% to 98.5%.• Created and implemented first of its kind forecasting tool used to plan manufacturing output resulting in more efficient use of labor and raw materials.• Reduced manufacturing lead time from 8 to 6 weeks, increased inventory turnover from 1.2 to 1.7 per year and decreased workforce headcount by 25%.

Anaheim, Ca

Managed a ten-person team responsible for all purchasing, raw materials and finished goods inventories, and receiving and shipping at two off-site warehouses. • Directed the implementation of computerized MRP system that reduced WIP by 15%.• Provided direction to manufacturing sites in Europe from start-up to full-scale commercial manufacturing, including purchase of equipment and design, layout and scheduling of the plant.• Purchased $25 million in raw materials annually, controlling inventories to achieve a 50% improvement in inventory turns and reducing price variances by over $1.5 million

Mission Viejo, Ca

•Established and staffed first RA/QA function during start-up stage.•Developed and implemented Quality Systems in accordance with FDA/GMP requirements, including SOPs and processes to move from a pilot operation into a full scale manufacturing operation.•Developed and validated ETO and radiation sterilization processes for all sterile products