Ruben C. Email & Phone Number

Louisville, Colorado, United States

Evaluate QMS processes and ensure they were efficient and scalable with the growth of the business, lead the maintenance and continual improvement of the QMS, ensure regulatory compliance at all levels of the business. Lead the effectiveness and compliance of the organization with ISO, ITAR and FDA requirements and in the education of staff to ensure their knowledge of the QMS while verifying the quality of all products and that all required records are maintained.• Have the authority to stop any production process if there is any issue with the quality of materials being used or produced as well as any shipments that do not meet quality requirements until the quality of the shipment can be verified.• Ensure the QA laboratory provides accurate, on-time quality control services to the company and our customers, while validating the laboratory is in compliance with all standards, and keeps accurate well-organized records, and stays aligned with corporate goals.• Work with third party agencies as needed to ensure regulatory compliance at all levels of the organization, schedule and conduct audits of the QMS processes to ensure they are efficient and scalable to grow with the company’s needs.•Ensure the quality department schedules meetings and training sessions with all personnel to ensure continued compliance with established quality standards. • Oversee the following processes: Internal Auditing, Customer Feedback, Change Orders/Document Control, Non-conforming Material, Deviations, Employee Training, Product Acceptance, Corrective Action and Preventive Actions, and calibration.•Schedule and conduct audits of the QMS to the ISO 9001, ISO 13485 standards and ITAR requirements as required, including those requested by customers.•Coordinate with the Supply Chain Manager and schedule supplier audits as necessary to insure continued supply of high-quality raw materials to the organization.•Have the authority to approve training, documents & testing up to $10,000.

Healthcare Division

Oversee the development, implementation and maintenance of plant quality systems in a cGMP driven environment. Participate and manage customer, supplier, internal and external audits. Implement and oversee training of the company’s employees to obtain compliance to internal and external interested parties’ standards. Oversee quality department staff and direct other staff as needed, evaluate employee’s performance and make recommendations about career development.• Rebuild the entire plant quality organization while addressing multiple manufacturing defects and avoiding recalls.• Maintain the company’s ISO 9001:2015 certification and successfully complete more than fifteen customer audits in a six-month period.• Analyze technical quality agreements, make recommendations and perform GAP analysis.• Manage continuous improvement efforts, set up quality goals and analyze internal performance metrics.• Improve productivity through positioning of lean manufacturing assembly lines and implement lean principles creating corporate benchmark standards.• Standardize quality systems (procedures, work instructions and forms) across several sites, and support other sites during audits.• Implement and manage the CAPA system and handle customer feedback, establishing corrective measures when needed• Report plant progress on achieving KPI’s and meeting goals during quality meetings and Management Reviews. • ISO 9001:2015 Certified QMS Internal Auditor• AS9100D Certified Aerospace QMS Internal Auditor

Responsible for revitalizing the quality assurance system while managing the QA team that promotes customer satisfaction and that positively impacts the financial performance. Champion defect reduction initiatives to improve upon the existing Quality Management System (QMS) while initiating and implementing quality improvement activities as appropriate to raise the performance of the company’s product lines. Maintain the ISO documentation, auditing and compliance for all certified locations while serving as the primary quality control resource for problem identification, resolution, loss reporting. Support concurrent engineering efforts by participating in design development projects representing quality assurance and the customer and design, implement and document procedures for process control, testing and inspection. Maintain and establish new metrics as needed –KPI’s, for monitoring system effectiveness and to enable managers to make sound product quality decisions.Perform root-cause analysis and other problem solving activities to identify effective corrective actions and process improvements and establish collection and analysis systems of statistical data to predict trends that will affect improvement of product quality. Analyze customers’ product specifications to establish efficient, cost-effective requirements for ease of manufacture and repeatibility, and develop quality planning methods for all product lines.Monitor vendor performance and establish criteria and rating system for critical vendors and review customer purchase orders, contracts and change requests to ensure that the necessary criteria and provisions are included in quality and process plans.Interact with customers to identify opportunities to improve quality and establish feedback with manufacturing and service personnel and report to senior management quarterly on quality issues, trends and losses.

Petaluma, California

Responsible for the areas: Inventory Management, Outbound Logistics, Commercial and Technical Customer Care, Documentation, RMA management as well as ad-hoc repairs/light manufacturing.Implementation of processes identified to improve the overall performance of the Order-to-Cash cycle.Development and implementation of customer service and tech support policies as well as procedures that support company wide strategic goals.Identification and recommendation of needed changes to the standardized processes for planning, receiving, picking, consolidation, shipping and invoicing. Creation and implementation of plans to improve supply chain performance with an emphasis on Inventory Control, Logistics, Traffic and Shipping, as well as Fill Rates, Delivery, and Customer Satisfaction.Looking for ways to optimize transit time and inventory locations to respective sister companies and customers outside the United States.Optimization of the Operations Organization and making staffing decisions based on company needs.Direct supervision of employees in the Operations, Logistics and Customer Service Department. Responsible for the overall direction, coordination, and evaluation of these departments. Direct supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.Responsible for the creation and monitoring of department budgets.Providing reports on a (monthly/quarterly/ad hoc) basis with commentary outlining reasons for variance in data (productivity, service, etc).Developing and carrying out an action plans for improvements.Ensuring customer orders are received, processed, and shipped accurately and in a timely manner.

Petaluma, California

Direct and maintain Quality Assurance and Control systems and activities for Hardware and Software products, ensuring that all procedural systems are in place and in compliance with Best Quality Practices.Manage others, as well as act in an Individual Contributor role, taking direct responsibility for execution of tasks.Stay current with all regulatory standards for US and International markets and determine applicable standards for FrontRow products.Ensure that continuous quality improvement activities are defined, implemented and measured for effect based on measurable data.Lead the internal Quality System Audit program and maintain Company’s ISO9001 certification.Implement and manage the corrective action reporting (CAR) system.Review technical problems & procedures of departments, identify root cause and recommend solutions to upper management on all product quality incidents.Manage the equipment calibration program.Work closely with Operations and Procurement to support supplier selection, development, and audit procedures through monitoring, review and quality analysis of suppliers.Write and Review Product Standards; including workmanship, reliability, cosmetic, safety, and other standards related to design and manufacturing of mechanical and electro-mechanical assembliesResponsible for final QA of parts, subsystems and productsSupport cross functional teams and bring an independent view of new product design proposals and returned product defect analysis, to help ensure new product designs are 'robust'Ensure designs are specified to minimize negative impact from typical changes in the manufacturing process and component selectionsGenerate deviations and ECO’s to document fixes or improve design/manufacturability as neededParticipate in Pre-Production Technical Reviews with new suppliers prior to full production releaseImplement and manage use of field complaint databaseDrive a strong and committed culture of quality throughout the organization

Capistrano Beach, California

Manage teams in areas of quality management and operational excellence in a high volume diversified manufacturing environment.Hands on management style, attention to details and leading by example.Support business unit financial objectives through management of the cost of nonconformance.Communicate with customers on quality issues.Form positive and productive customer relationships based on data and continual improvement.Identify, direct and mentor quality improvement teams.Implement training programs in support of continual improvement.Develop and maintain a sustainable quality management system to support the business unit objectives to comply with ISO StandardsPlan, schedule and carry out internal audit programs to comply with ISO/AS/MIL-STD standards.Establish internal and external quality performance metrics based on operational excellence principles and holds appropriate quality personnel accountable for performanceProvide coaching to staff, peers, associates and management team, thereby enhancing their skills in efficient execution of procedures to drive improved customer satisfaction.Provide quality performance reports and reviews to the general manager, functional leaders and customers.Interface with process engineering to share best practices.Manage and interact with vendors on quality issues.Implements and maintain a system to review and to flow down quality clauses and customer requirements into internal procedures.

Promote and implement technological innovationsManage a high-level network of external correspondenceFind a compromise when faced with complex technical choicesIdentify technical risksUnderstand the links between product performance and choice of architectureMake realistic commitmentsGenerate confidenceWork in a multicultural environmentDecide quicklyConvince others of my choicesManage a subcontractor / partner in my fieldPlan the milestones of a design projectDraw up a development plan (deliverables, tasks, schedule)Set product cost targetsAssess the relevance of a product qualification planHave an overview of the performance features of competing productsCapable of reconsidering ideasPresent a file clearlyTake marketing aspects into account in my reasoningInterpret marketing data in technical termsRank and manage prioritiesTraining in Virtual design tools (Pro-Engineer) and methods, FMEA, Calculation of methods in field

Identifying key quality parameters during development cycleCreates quality plans that assures parameters are measured and controlledOn-going analysis/product testing during development stagesLead in the resolution of quality concernsEnsures quality standards are met by suppliers of purchased componentsEnsures PI goals and metrics are met. Working closely with marketing teams to ensure product development efforts meet the company's high quality standards.Coordinate regulatory agencies tasks such as, data compilation, organization and preparation of regulatory documents, CPSC, FDA, Health Canada, UL, and USP.Development and Preparation of 510k's, PMA's for both the US and Canada, including but not limited to test data, performance claims, device classification, intended use, applicable performance standards, predicate devices and labeling.Maintain product approval, completing and submitting all the requirements of the regulatory bodies, such as FDA's device listing and manufacturer listings.Primary contact with regulatory agencies such as FDA, Health Canada and UL for the assigned products.Support product development team and ongoing quality improvement efforts domestically and internationally in determining resubmission or changes of 510k's, including extensive travel throughout Asia, North, Central and South America.Support suppliers and contract manufacturers in order to comply with GMP guidelines, clean room directives and device sterilization.

Responsible for the design integrity of assigned products, which encompasses performance, functional and reliability characteristics of electrical, mechanical and temperature controls. Conform to established engineering practices. Ensure the products are adequately designed to meet or exceed any agency, such as UL, CSA, CE, NEMA, military, automotive, aerospace, customer or company requirements. Approve or create all necessary product specifications and drawings. Coordinate and report on work requested through the engineering project request (EPR) system. Approve and identify routing of engineering change notices (ECN's) and temporary engineering changes (TEC's). Evaluate and approve requested product or part deviation from specifications. Establish product reliability test programs. Analyze and report on any non-conformance. Provide necessary engineering documentation for cost estimates. Provide support to manufacturing on related product design issues. Provide support to sales and marketing on customer related product issues. Coordinate the build of any special parts or products for sample orders. Participate in internal quality audits (ISO9000) on assigned products. Evaluate, test, and approve any material productivity changes. Participate in new product development or product line extension activities as required, using tools like COSMOS, PRO-E or any other software needed for FMEA and FEAMaintain awareness of technology developments in assigned product areas or markets. Participate in customer visits by providing presentations on program updates and technical design reviews. Assist in the analysis of field returns to determine causes and resolve problems. Technical liaison to facilities located in Spanish speaking countries.

Translate engineering documents such as AWWA and ASTM specifications. Interpreter for guided plant tours. Collaborate in the production of promotional engineering material to be distributed in Spanish speaking countries.

Performs various tasks assisting the metallurgist.Furnace/Salt purity analysis.Tests apex and competitors' parts.Prepare overall analysis and test results in a presentable format.Mount, prepare, and examine specimens for microstructure and microhardness analysis.Perform/assist with uniformity surveys on heat treat furnaces.Work with manufacturing engineering to perform capability studies.Track gauge inventory.Use of advanced computer equipment.

French As A Second Language, Mechanical Engineering

Master Of Science (M.S.), Materials Engineering

Bachelor Of Science, Mechanical Engineering

Bs, Industrial Engineering