SUMMARY

• Quality and Manufacturing Engineering: Floor support and day to day operations, creation of procedures, inspection plans, Non - conformance investigations, Corrective/Preventive Actions (CAPA), supplier qualifications, continuous improvement projects, cost savings and cost reductions projects, change management, statistical analysis, Gage R&R, trained in six sigma black belt, root cause analysis and DMAIC methodologies. ination with multiple departments, supplier audits, ensure timeline is met. Perform testing or equipment and process validations as required for Quality or Manufacturing Engineering.
• Ensure continuous supply chain while transfers are moved into production. Creation and characterization of new manufacturing processes and inspections. Determination and review of manufacturing drawings, specifications and limits. Post Market Review Analysis for manufacturing and quality departments.
• FDA Readiness, Quality Compliance (FDA 820), Remediation: Highly experienced in leading, establishing and executing plans for Regulatory and Quality Compliance remediation projects. Developed Compliance Master Plans for FDA observations in different companies.
• Participated as Process Validation expert and Engineering Manager in FDA Audits.
• Experienced Manufacturing Engineering Manager in charge of 10 engineers and 4 technicians with global responsibilities, responsible for Sustaining Engineering, Day to Day floor support (non-conformances etc.), New Product Development projects, Equipment and process validation, continuous improvement and cost saving projects, Product and Process Transfers and Engineering CAPA’s.
• As a consultant managed 25 engineers, made sure all employees were completing project milestones on time, met with clients to ensure expectations were being met. Complaint investigation associated to manufacturing and quality systems.
• Reviewed Post Market surveillance reports and supported actions required to improve product performance.
• Working experience with machining processes (CNC, lathes, mills), chemical processing equipment (anodizing, cleaning, polishing, surface finishing etc.), laser marking, molding, packaging and inspection equipment used for metal implants.

PROFESSIONAL EXPERIENCE

Confidential

Senior Quality Engineer

Responsibilities:

• Responsible for Test Method Validation (TMV) remediation of current test methods and creation of a global validation system.
• Provided compliance assessment of current Test Method Validation (TMV) System, procedures and practices and contributed to the development of new architecture including creation of policy, procedures, templates, protocols, reports, for the Global Confidential organization
• Developed training material and provided training for the roll out of new global Test Method Validation system, including statistical analysis (gage R&R) and requirements for sampling.
• Created and standardized visual standards and procedures to perform the test methods.
• Analyzed drawings and design specifications to make sure that requirements were established, tested and met for required devices.

Confidential, Palm Beach Gardens, FL

Global Concurrent Manufacturing Engineering Manager

Responsibilities:

• In charge of Manufacturing Engineering team responsible for product transfers and new product development and introduction (NPI) to operations in addition to sustaining engineering for the Palm Beach Gardens FL site.
• Successfully managed projects and team members to complete 20 NPI projects involving global responsibilities for Biomet Dental facilities in Palm Beach Gardens, Florida and Valencia, Spain.
• New product introduction projects included product transfers from suppliers, transfers from site to site, creation of new products (processes) and distributed by products. In addition to introduction of new equipment and technologies such as chemical cleaning processes, bead blasting for roughened surface metals and 3D printing for rapid prototyping.
• Created Manufacturing Plans detailing manufacturing engineering responsibilities and deliverables based on design requirements in order to complete successful and compliant new product introductions and transfers into production.
• Created product based PFMEA templates and procedure as part of the Risk Management team.
• Reviewed and approved documentation regarding new product development process such as design & development plans, design input/output traceability matrix, design specifications, drawings, risk assessments, hazard analysis, process flow charts and post market surveillance review.
• Wrote, reviewed and approved manufacturing and quality procedures related to machining, chemical processing, cleaning, laser marking, packaging, sterilization and QA inspections through change control process and performed periodic reviews.
• Provided constant local and global support in the problem solving, root cause analysis of CAPA’s and complaint investigations related to manufacturing operations and engineering for both the Palm Beach Gardens, FL and Valencia, Spain manufacturing facilities.
• Wrote, reviewed and approved CAPA’s and Non-Conformances as part of the CAPA Board and completed CAPA’s related to Equipment/Process Validation, improvements to the CAPA system, Design Controls, Risk Management, engineering improvements, design transfers into production.
• Monitored completion of CAPA’s for the engineering team.
• Implemented investigation tools in the CAPA procedures to improve the root cause analysis process such as 5-why, is-is not, and Ishikawa (fishbone) diagrams.
• Used Six Sigma, DMAIC, Kaizen, poke yoke, fishbone diagrams, 5 why and other root cause tools to identify solutions to issues identified through Non-conformances and CAPA’s on the manufacturing floor. Provided guidance to engineers as needed in problem solving activities.
• Performed Supplier Tech reviews and supplier quality reviews for new suppliers.
• Performed engineering studies to support cost savings projects by improving cycle time, improving tolerances, decreasing setup times, inspections and sample sizes.
• Created KPI’s for manufacturing operations (safety, on time delivery, cycle time) including quality operations (Non-Conformance, CAPA’s, rejects, reprocess etc.).
• Supported Value Stream Manufacturing Engineering on sustaining and improvement projects as well as provided pilot cell and engineering resources for completion of these activities.
• Supported and participated in the creation of a Compliance Master Plan (CMP) due to FDA 483 observations for the FDA Readiness, CAPA, Production and Process Controls, Design Controls, and Risk Management work streams.
• Completed gap analysis for compliance to ISO 13485, FDA Regulations Part 820 and GHTF for validation and process controls and aligned all sites.
• Revamped and created new procedures for Global Process Validation System in order to comply with FDA regulations. Created all new IQ/OQ/PQ protocol and report templates, process monitoring procedures, deviation forms and engineering study templates for the documentation and characterization of process improvements and process changes.
• Participated in the DHF remediation as part of the Design Controls team.
• Completed FDA responses and improvements needed for FDA observations (CAPA, Design controls and Process Validation) effectively and on time.
• Led efforts on remediation projects in Valencia for validation of cleaning processes and water system improvements. Made sure validations were compliant to quality standards and regulations.
• Completed successful BSI Audit in May 2014 as the process and equipment validation expert.
• Part of the FDA audit as production and process controls/validations expert.
• Managed budget effectively and worked well with other multifunctional teams (marketing, supply chain, regulatory etc.).

Confidential

Product Transfer Manufacturing Engineer

Responsibilities:

• Generated all documentation regarding transfers quality plans, change requests, routers, BOM’s, control plans project plans, validations, machining jobs, OPP’s and purchase orders.
• Managed budget effectively and worked well with a multifunctional team that includes value stream, purchasing, accounting, regulatory, quality, supply chain and planning.
• Also performing transfer of components from current supplier JBiomet to LX Precision.
• Participated in Kaizen activities for the standardization of our design process and customer order form improvement. Revamped current procedure for “Design of Abutments” by standardizing design and providing visual inputs for the operator to follow.
• Participated in all Global Manufacturing Engineering Team meetings and taking on the responsibility of giving continuity to all projects assigned to our team by assisting team members in their daily scope of work and allocating resources as needed.