▪ Quality systems consulting and training for the pharmaceutical and medical industries (FDA CFR Part 820, Part 210 & 211 (cGMP’s), ISO 9001, ISO 13485). ▪ Consulting services for other industries and support efforts to obtain certifications in a variety of standards, including AS9100, ISO 14001, ISO 17025, and ISO 45001 (OSHAS 18001.) ▪ Training on Metrology concepts, GD&T ASME Y14.5, Statistical Process Control, Internal Auditor in various ISO standards, and Lean Six Sigma tools and methodology.▪ Quality Engineering Support (NCR’s, CAPA, Cal system, Risk Management -PFMEA, Statistical analysis, Document Control, Change Control, Auditing, Validations, Training), and Project Management.▪ Translation services (English/Spanish)

I have served as a lead-judge for preliminary rounds of the International Team Excellence Awards competition and served twice as a final judge for this event.Hundreds of teams from the world’s most successful companies participate in this competition, showing how they have successfully implemented continuous improvement projects and how they have applied quality concepts and tools to improve quality and profitability in their organizations.

Oversaw, managed, and fully executed the overall manufacturing effort with the objective of maximizing profitability. Successfully transferred the manufacturing operation from West Chester, PA to Juarez, Mexico (including transfer of 120 machines for various processes, training of personnel from Juarez, and validation support for the receiving site). Developed and coordinated strategies and objectives geared towards continuous improvement. Hired and developed personnel to meet objectives. Set and monitored operational budget performance. P&L responsibility of 24M. Ensured smooth transition from concept/design stage to manufacturing process development in a productive and safe manner. Interfaced with internal and external customers in order to maintain project deadlines. Provided oversight and managed production, scheduling, facilities, safety, materials management, procurement, and engineering. Operations included manufacturing of graphic cases, trays, modules, and surgical instruments.▪ Worked closely with quality to ensure 100% compliance with all regulatory requirements for the site (ISO and FDA).▪ Worked with HR to implement proactive people management programs. Set standards for performance assessments, feedback, and effective communication. ▪ Managed engineering teams and established goals for cost reduction initiatives in all functional areas.

Established goals and strategies for four departments; managed three supervisors and five cell leads to accomplish assigned objectives. Managed a group of eight manufacturing engineers, nine technicians and tool makers in design and development of manufacturing processes for existing, new, and transfer products. Directed projects for machine evaluation and selection, automation possibilities, fixture design, manufacturing procedures, layout, process testing, machine programming, process validation, and cost analysis. Operations included manufacturing of graphic cases, trays, and modules. Managed 18M budget for the business unit.Maintained an effective safety program in the unit. Acted as Functional approver for the CAPA review board ensuring prompt resolution of root causes and implementation of effective corrective and preventive actions.▪ Successfully executed a two year remediation plan to resolve an FDA Corporate Integrity Agreement and ensure full compliance with all regulatory QSR and ISO requirements during planning, scheduling and manufacturing of existing and newly created products. ▪ Identified and promoted continuous improvement opportunities in quality, cost, and time to market for the organization. ▪ Successfully installed a farm-in program to reduce external processing contributing to cost reduction for subcontract costs and reached 99.6% quality acceptance level in finished product.▪ Maintained a Lean /Six Sigma program in the unit by driving kaizen events, SWOT analysis, Value Stream Mapping, 5S, etc. Conducted monthly Gemba walks to ensure timely problem resolution on the production floor.▪ Effectively incorporated the “Know Our People” interviews program and the Appreciative Leadership concept to improve employee morale.

Managed implementation of the Quality System after acquisition of American Manufacturing Tech Co. by Synthes. Maintained up to date training of quality engineers, manufacturing engineers, and technicians. Formulated and revised documents to support company quality, compliance and manufacturing objectives. Managed the Calibration laboratory, CAPA, and Complaint systems.▪ Served as Chairperson and ensured plant wide Material Review Boards were effective and timely. ▪ Applied all Calibration System and Risk Analysis requirements within a two month period to accomplish ISO certification for the Jennersville plant in 2010. ▪ Incorporated new processes and technologies in support of Manufacturing Engineering during transfer from American Manufacturing Technology (AMT) to Synthes in 2006. ▪ Eliminated waste in the assembly templates process obtaining Green Belt certification through completion of a Six Sigma Project. ▪ Supervised six Quality Engineers tasked with responsibilities in validation, new product transfer, supplier management, packaging, inspection plans, manufacturing support, CAPA, complaints, and calibration.

Reviewed and granted approval on ECN’s (DCO’s), served as ECN board facilitator. Executed complaint investigations and dispositions of NCR’s, and Gage Statistical Studies on measurement and test equipment. Supported operations including manufacturing of bio-medical materials, collagen products, polymers, catheters, and vascular closure devices.▪ Validated biomaterials, extrusion and molding manufacturing processes; created PQ protocols and FMEA’s.▪ Acquired and qualified new technology including CMM and tensile testing systems. ▪ Concluded realization and training of Gage Statistical Studies and procedures and applied to tensile testing.▪ Acquired and validated X-Ray technology for biomaterials inspection; created work instructions and conducted training on use of the equipment including radiation safety.

Supervised 14 incoming Inspectors and Metrology personnel, assured components received for manufacturing were in compliance with established requirements and managed the Calibration System. Supported Endoscopy and Disposable Instruments divisions.▪ Decreased calibration costs 50% via integration of an in-house Calibration System.▪ Conducted internal and supplier audits in the US for compliance with QSR and ISO standards.▪ Formulated action plans for NCR reduction and continuous improvement as an ongoing goal. ▪ Scored over 75th percentile on Gallup Workplace Survey for Supervisor’s Performance for two consecutive years. ▪ Trained personnel in Metrology concepts, statistics, measuring systems programming, and GD&T.