Jorge Rojo Email & Phone Number

Nogales, Sonora, México

Nogales, Sonora, Mexico

• Provide leadership to the quality team while focusing on product quality by supporting overall business results• Support the planning, scheduling and execution of the production plans activities that support team and business objectives• Ensure compliance with the requirements of the quality management system ISO13485, US FDA 21 CFR Part 820, MDSAP• Develops, applies and revises quality standards for receiving, in-process and final inspection• Internal and external audits, exercises of preparation, execution and response to the findings of any audit.• Lead investigations of customer complaints and product nonconformant • Ensure manufactured products meet the established quality requirements and obtain a proper material utilization.• Liaison between plant quality department and customer quality department of Tecate and Tucson Facilities • Ensure a high level of safety awareness, maintaining a safe and clean work environment• Monitoring and maintenance of environmental controls and cleanrooms class 8 and 9 for manufacturing processes • Development of risk assessment and technical investigation• Responsible for developing, managing and implementing the projects in a specified time and manner• Detect opportunities for improvement in methods and processes, introduce and implement new processes and products• Create, update and manage Device Master Record for new and/or existing products.• Contribute to change control activities and the evaluation of new or current suppliers• Interface with customers, vendors and various company departments to resolve quality problems and provide information.• Validation Master Plans, Equipment Qualifications, Process Validations, and test method validations • Implementation and maintaining of risk files: flow chart, control plan and pFMEA • Responsible of blow molding, extrusion, manual assembly process, injection molding and canula dipping process

Nogales, Sonora, Mexico

• Identify and implement effective process control systems to support the development, qualification, and on-going manufacturing of products to meet or exceed internal and external requirements.• Lead in the implementation of assurances, process controls, and CARs systems designed to meet or exceed internal/ external requirements.• Acts as an effective leader or team member in supporting quality disciplines, decisions, and practices.• Apply systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.• Assure in the development and execution of streamlined business systems which effectively identify and resolve quality issues.• Participates into the definition, validation and closure of corrective actions from customer concerns, deviations and engineering changes • Manage Quality System for Aerospace ensuring compliance to all applicable requirements in AS9100, QMS-1000, GD&T and NADCAP • Liaison between plant quality department and customer quality department. Such: Shelby, Boeing, Roll Royce, Eaton, Nordmicro, Triumph, Honeywell and Woodward. Lead external customer visits in manufacturing area. • Provide leadership to Quality Inspectors, Technicians and Engineers to ensure that products and processes comply quality system. • Leads Problem solving activities using tools such as 8Ds, DOE (Design Of Experiments), 5Why’s, etc • Leads actions towards resolution on Warranty Failures related with the manufacturing process.• Monitoring Customer Scorecards and establishes action plans to meet or exceed Customer expectations. • Leads capability studies to process validation (Equipment’s/tools/fixtures). Statistical studies such as GR&R, CPK, SPC • Follow up and improve quality to achieve goals (DPMO, OTD, Repair, Scrap and PPM). • Supports and/or participate on Continuous Improvement Activities such as: Kaizen, Ideas Programs, cost out improvements

Nogales, Sonora, Mexico

• Develops, establishes and maintains quality engineering methodologies, systems, and practices which meet customer BSC, • Serves as a Quality representative to improve awareness, visibility, and communication on quality initiatives to support departmental, functional, site, divisional and corporate quality goals and priorities. • Provides focused quality engineering support within new product development, operational, or system/services support.• Responsible of Injection molding, manual and automatic pin insertion and final assemble automotive connectors• Responsible of LPA audits, internal and external audits QS 9000, ISO13485, IATF 16949 • Experience contact worldwide with Apple, Huawei, IBM, Autoliv, Continental, Lear and GM.• Conduct packing validation (manual and mechanical handling)• Conduct Go and see Reverse FME, prepared customer specific PPAP submissions, gage R&R, FMEA and control plan• Monitor and control key performance indicator (KPI) Safety, Customer complaints, delivery, Scrap, downtime, productivity• Drive defect containment and assure problem resolution in a timely manner for quality issues impacting production lines and customers• Analyze quality data and initiate root cause and corrective action efforts to eliminate assignable causes that affect product quality. • Develop and execute manufacturing processes and measurement equipment validation PPAP, FAT, CSV, TM V, IQ, OQ and PQ

Nogales, Sonora, Mexico

• Quality system migration and product introduction of blow molding safes from Rochester, New York to Nogales Master Lock• Quality System Management implementation of blow molding area (procedures, work instructions and formats).• Ensures metrics are provided for quality reporting (e.g. Quality Management Review, CAPA Review Board, and in-process quality trends; complaints analysis, calibration, etc.) is maintained and documented.• Compiles and writes training material and conducts training sessions on quality control activities. • Participant of Gemba board meeting monitoring and communicating current status of the business unit and align actions and decisions • Drive defect containment and assure problem resolution in a timely manner for quality issues impacting production lines and customers• Assures data availability and integrity for all quality related data. Consolidates and reports quality results.• Designs and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products/process • UL manufacturing audits to mitigate supply chain risk, protect brand reputation and promote consistency through verifying quality management • Responsible for investigation Customer Complaints, CAPA’s and Internal rejection using fish diagram, 8 disciplines and 5 why’s • Develop CTQ’s, PFMEA’s and Control Plans with a multidisciplinary team for new or existing products and processes.• Coordinate any documentation and quality related issues during the launch phase of new product.• Responsible of plastic area (blow molding, insulation, injection molding, incoming inspection and final assembly)

Nogales, Sonora, Mexico

• Responsible for process and equipment validation (FAT, CSV, TM V, IQ, OQ and PQ) including Class I, Class II, and active medical devices, non-invasive, invasive. CTQ’s, PFMEA’s and Control Plans • Develop and execute training, including competence assessment, for quality-related processes and procedures• Work cross-functionally to conduct root cause investigation, action planning and verification of effectiveness for CAPA• Manage Quality System for Health Care ensuring compliance to all requirements in ISO 13485, CE MARK, FDA/GMP, 21 CFR 820.• Responsible for Injection and Extrusion molding areas (Scientific Molding application)• Perform gap analysis on existing documents, assess, and revise to current QMS DHF and DMR documents requirements. This includes design, process, risk management, and other quality system documents.• Work with cross-functional team (Quality, R&D, Regulatory, etc) to resolve complex engineering gaps and concerns found • Develops sampling plans by applying attribute, variable, and sequential sampling methods• Molding validation: Lead/support creation of IQ/DOE/OQ/PQ validation protocols and reports• Responsible for being a communication liaison between the customer and manufacturing facility• Perform investigation of product non-conformance/complaints, root cause analysis, monitoring/trending of process and product.• Execute risk assessment as needed and facilitate development and completion of risk file documentation.