Hiram Rojas García, P.E.

• Under the guidance of the Site Leader, lead a multifunctional team in support of site project portfolio aligned with the site strategies and goals. Partnered with other sites, and functions in the identification, definition, and execution of projects ensuring proper prioritization, and resource allocation. Encouraged and supported the identification and development of innovative solutions to problems and opportunities with increased responsibility including, but not limited to, additional skills, multiple lines/products, product transfer and launches, etc.
• Responsible for the oversight of project execution and/or site programs under the site PMO to ensure flawless execution, resource allocation, and project prioritization in alignment with the organization’s strategy.
• Responsible for the tracking of the project portfolio and/or program execution, identifying possible risks and mitigation plans. Collaborate with the Leadership Team to drive adherence to the site’s strategy, capital investment, and savings plans.
• Lead and support business cases development to confirm capital investment, savings and/or benefits.
• Enable the delivery of projects to ensure Project Portfolio financial targets (capital, expense, and savings).
• Lead projects to standardize and improve project performance and monitoring.
• Lead / Support ideation process to identify projects for project pipeline development and support Business Plan, and Long Range Financial Processes.
• Responsible to provide update on resource management, CIP and capital spending to PPM Team, Senior Management and external applicable teams.

Responsible for overall Quality Assurance and leadership in the management of quality impacting suppliers and purchasing control systems.

• Identify and eliminate supply chain risks, ensure suppliers are technically competent, lead supplier quality development, and ensure that supplier’s and internal practices are executed in compliance with company requirements and applicable regulations.
• Key areas of focus are risk management, defect resolution, supplier process capability / improvement, supplier and QMS performance monitoring, and quality assurance general support.
• Responsible for supporting health authority inspections, completing department / franchise objectives as assigned while demonstrating Credo values and behaviors.
• Lead Supplier Quality Agreements Program
• Coordinate and/or lead key investigational and/or risk management projects within vendor facilities. Establish, monitor and implement supplier risk mitigation plans. Ensure compliance with JJV Quality Systems and/or project charter deliverables, while interacting with Supplier personnel to collaboratively achieve improved supply chain performance. Report on the overall status of such initiatives, ensuring key issues are escalated as necessary.
• Follow through on RM defects, ensure root cause identified with appropriate vendor corrective actions, reduce overall supplier NC’s. Collaborate with operations to confirm if non-conformances are raw material related.
• Independently lead internal and/or external cross-functional and cross sector project teams driving supplier improvement and general initiatives. Ensure professional communication of project progress and outcomes to key stakeholders. Reduce variations in supply chain, institute vendor control plans, and improve vendor process capability. Provide Quality Engineering support to suppliers including verification/validation activities. Apply Quality Engineering tools such as Failure Mode & Effects Analysis (FMEA), Fault Three Analysis (FTA), Root Cause Analysis, Design of Experiment (DOE) etc., to the development of new products or processes related to raw materials and supplier processes.
• Establish metrics, monitor and report on performance, and hold quality business reviews. Develop and report supplier performance metrics. Identify and drive implementation of best practices/processes at suppliers.
• Provide regulatory guidance and interpretation to internal and external partners as well as suppliers with regard to the following areas: medical devices, API manufacturing, aseptic processing, combination products, and ophthalmic solutions.
• Coordinate approval of supplier change control requests. Participate in local site supplier quality meetings to ensure communication and alignment of quality initiatives. Lead supplier quality evaluations. Provide third party inspection support.
• Serve as back-up to SQ Manager. Fully understand supplier procedures and, as necessary, independently lead supplier issues, projects and challenges. Lead supplier assessments. Fully understand and demonstrate core knowledge of key supplier contacts, facilities and products.

• Manage and lead robust failure investigation for PQI (Product Quality Issues), CAPA (Corrective and Preventive Actions) and NCR (Non-Conformance Reports) while driving timeliness and compliance.
• Analyze quality data and identify systemic trends impacting risk benefits requirements of product and quality systems with primary responsibility for the maintenance of External Manufacturers and Packaging Raw Material Suppliers.
• Ensure compliance to the Johnson and Johnson enterprise, sector and franchise policies and procedures such as Design Control, Change Control, Process Validation (IQ/OQ/PQ), Test Method Validation, Sampling Plans Development and Review, and Supplier Management.
• Support regulatory inspections and compliance audits.
• Played different roles in support of notified body and internal audits at the Ethicon LLC Principal structure at Guaynabo such as backroom lead, scribe, and document reviewer.
• Lead risk assessments for unacceptable supplier audits.
• Lead supplier technical assessment audits.
• Collaborate with external operations on process/product improvement projects. Provide recommendations or proposed changes based on data analysis.
• Collaborated with a barbed sutures external manufacturer to conduct a Batch Record Review Kaizen to reduce record review time by 35% which has an estimated annual cost avoidance of $35K.
• Support external manufacturing transfers.
• Led Quality Plan for the transfer of a manufacturing product line for Ethicon barbed sutures to ensure business continuity and continued quality of product delivered.
• Lead component qualifications for supplier changes to ensure material availability for packaging needs.

• Assisted in Business Plan development by conducting Machine Capacity Analyses, Batch Change, and Material Replenishment Time studies for different machines to reduce changover times.
• Assisted in Automation Center of Excellence Base Business Initiatives by supporting CIT (Continuous Improvement Team) and IPT (Integrated Production Team) tasks such as production capacity and product flow analyses.
• Provided support to the Automation Center of Excellence Lean Initiatives by instructing group leaders and associates in conducting and documenting continuous improvement events.
• Automated Packaging Machine Batch Change Kaizen - led the operations team in the batch change process analysis and in the development of an action plan to improve the machine's availability.

• Performed preliminary assessments on technical information as part of contract closeout processes.
• Supported failure investigations regarding technical issues leading to NCRs.
• Provided support to the QA department on NCRs closeout.
• Performed desktop audits on design, and start-up phases of the project.
• Supported design reviews associated to the project line structure and intermodal facilities.