José M. Ortiz

Objective

Seeking a challenging engineering position where my extensive experience and application of quality systems, product development, project management, manufacturing operations and international regulatory guidelines will contribute to provide state of the art quality products. Member of American Society for Quality (ASQ), AAMI, Certified Quality Engineer (CQE), ISO 13485 Lead Auditor by RABQSA, Professional Engineer. Past Vice-Chair for ASQ Section 1312.

Professional Experience

Feb 2022–Present Pharma-Bio Serve (Alcon) Johns Creek, GA Consultant, Validation Engineer

Participated in process validation for new manufacturing platform for contact lens. Conducted software validation activities for SCADA and spreadsheet.

• Developed and executed process qualification protocols for new manufacturing equipment, and commissioning of utilities.

• Developed validation strategies and participated in qualification of SCADA system.

• Participated in execution of cleaning validation for new manufacturing lines.

• Conducted spreadsheet validation for chemical formulation process.

• Developed requirements, test protocol and execution protocol for formulation process.

• Led documentation of requirements, protocol development and execution of spreadsheet for laboratory equipment and integration into LIMS.

• Executed material qualification of alternate supplier. Oct 2021–Feb 2022 Planet Pharma (Cardinal Health) DeLand, FL Consultant, Quality Engineer

Represented Quality function in quality system improvement initiatives, complaint investigations and product transfer project.

• Assessed product release process to identify improvements and prevent shipment delays.

• Developed quality documentation needed to transfer product line from external manufacturer: quality plan, inspection plans for components, packaging and finished products.

• Investigated complaints for OEM customers on safety needle products.

• Supported CAPA investigations and preparation of management review presentations.

Feb 2013–Oct 2021 Philips Colorado Springs, CO

Senior Design Quality Engineer

Actively represented Design Quality function on product/process development teams. Provided guidance to Engineering staff and other personnel to ensure compliance to design control requirements in design verification, validation, specification and procedure development, risk management, statistical techniques, and design review. Participated in development of electromechanical software driven products. Led the Risk Management efforts managing product and process risks assessments. Facilitated identification of quality characteristics and inspection plans for components, assemblies, and finished devices. Achievements

• Team successfully launched six (6) new Class II and III devices for cardiac lead management.

• Team successfully launched a life sustaining device that had assisted in saving over 100 patients.

• Managed product risk throughout the development process with the use of FMECA and other risk management tools (uFMEA, DFMEA, PFMEA, FTA).

• Contributed to development of design input requirements from previously marketed competitive devices and/or other similar products.

• Developed human factors and usability engineering plan, formative and summative protocols and reports. Facilitated usability studies.

• Developed master test plans that encompass design verification, design validation and process validation activities. Creation, evaluation, and validation of product and process test methods.

• Evaluated test protocols and reports to ensure that the testing is sufficient to meet regulatory requirements and quality objectives.

• Coordinated QMS compliance audit with external design developer and external manufacturer.

• Managed multiple domestic and international suppliers for PCA, molded components and laser- cut tube assemblies during development, component qualification and design validation.

• Managed external manufacturer of completed assembly throughout development, process qualification, design validation, and transfer to production.

• Contributed towards development of design and manufacturing documentation including material specifications, drawings, inspection procedures, and manufacturing procedures, to ensure that the resulting devices can be adequately manufactured and tested.

• Active participant in product development including physician interaction, product engineering, competitive product testing, and prototype testing.

• Participated in product failure investigations.

• Assembled and maintained product design history files and technical documentation.

• Participated in compiling 510(k) and technical dossier for Class II and Class III products.

• Evaluated and dispositioned nonconforming materials and products used in pilot and clinical builds, to arrive at the most economical disposition, while meeting quality system requirements.

Mar 2015–Dec 2017 Philips Colorado Springs, CO

Principal Quality Engineer

Participated in remediation activities associated with FDA Warning Letter that included risk management process, design documentation, component qualification and process validation improvements.

• Updated risk management system to connect risk assessments with end-effects in post-market data and incorporated detectability in FMEA assessments.

• Revised risk assessment files and risk management reports for all legacy products.

• Reviewed DIDO traceability matrix to correlate with appropriate design test verification protocol/report and provided justification reports to cover gaps found.

• Developed Master Validation Plans to include effective traceability of process inputs and outputs to their respective IQ, OQ, PQ, PPQ and test method validation as applicable.

• Participated in development of appropriate design history file and device history records.

• Developed assessment of component qualification for multiple product lines and reviewed applicable component qualification protocols and reports.

• Participated in development of Master Component Qualification strategies.

• Participated in development of strategy to cover human factors and usability engineering assessments for multiple product lines.

Oct 2012–Feb 2013 Spectranetics Colorado Springs, CO Acting Manager of Post Market Surveillance

Responsible to coordinate and document post-market surveillance activities: complaint handling, adverse event reporting, device investigation, and integration of Field Service reports: Achievements

• Reduced average time to complete complaints from over 90 days to less than 45 days.

• Reduced average time to submit adverse event report from 28 days to less than 20 days.

• Established methodology to ensure timely adverse events reporting per FDA guidelines.

• Provided weekly summary of PMS metrics on complaint status and adverse events reporting

• Led investigation on complaints and adjudication of adverse events.

• Managed adverse event reporting in accordance to regulatory requirements.

• Developed operational metrics related to time to complete complaint and device investigations.

• Developed adverse event decision trees for multiple regulatory sites.

• Initiated integration of complaint handling data with product risk management.

• Developed Pareto charts for complaints by products, problems, root-cause, and physicians.

• Provided data analysis to support PMA annual reports and clinical evaluation reports.

• Managed 3 post-market surveillance analysts and 2 consultants. Mar 2011–Oct 2012 Spectranetics Colorado Springs, CO Principal Quality Engineer, DAE Team Leader

Actively represented Design Quality function on product/process development teams. Provided guidance to Engineering staff and other personnel to ensure compliance to design control requirements in design verification, validation, specification and procedure development, risk management, statistical techniques, and design review. Led the Risk Management efforts managing product and process risks assessments. Facilitated identification of quality characteristics and inspection plans for components, assemblies, and finished devices.

Achievements

• Team successfully launched four (4) new Class II and III devices for cardiac lead management.

• Managed Design Assurance Engineering Group (4 engineers) to support multiple product design and development projects.

• Identified and managed risk throughout the development process with the use of FMECA and/or other risk management tools. Lead the Risk Management efforts of the design team on managing product and process risks.

• Completed component qualification transfer to alternate suppliers.

• Developed master test plans that encompass design verification, design validation and process validation activities. Creation, evaluation, and validation of product and process test methods.

• Assessed test protocols and reports to ensure testing meet regulations and quality objectives.

• Active participant in product development including physician interaction, and product testing.

• Coordinated post-market surveillance activities. Analyzed and investigated returned products.

• Developed and maintained design history files for projects assigned.

• Participated in development of PMA product file and technical dossier for Class III products.

• Evaluated and dispositioned nonconforming materials and products used in pilot and clinical builds, to arrive at the most economical disposition, while meeting all quality system requirements.

• Conducted quality audits to external suppliers, third-party manufacturers, and internal areas. Feb 2008–Mar 2011 Spectranetics Colorado Springs, CO Sr. Quality Engineer

Ensure compliance with supplier management and design control procedures. Provide guidance on the application of design control procedures, risk management and statistical techniques.

• Led development of risk management documentation for new products (dFMEA and pFMEA).

• Participated in development of design requirements and product specifications documentation.

• Developed and executed design verification and validation plans, protocols and reports.

• Validated product test methods are robust and validated.

• Provided guidance on statistical analysis for verification and validation activities.

• Developed and executed process qualification protocols and reports. (IQ, OQ, PQ, and software).

• Prepared and maintained design history files for projects assigned.

• Participated in development of regulatory products submissions.

• Coordinated product release for commercialization.

• Participated in Change Review Board to assess design changes to sustaining products.

• Conducted investigation on product complaints, and CAPA issues.

• Conducted quality audits for external suppliers, third-party manufacturers, and internal areas.

• Developed supplier selection and qualification plans for the projects.

• Developed supplier management procedures: supplier classification, evaluation and monitoring.

• Developed procedures for component specification and qualification. Developed qualification reports and conducted investigation of deviations.

Nov 2007–Dec 2007 Weil Group (Angiotech, Inc) Rincón, PR Consultant, Validation Engineer

Responsible to qualify needle manufacturing equipment transfer from other facility:

• Developed and executed installation, operational and process qualification on needle manufacturing equipment: forming, bending, polishing, tapering, washing and wire cutting.

• Developed qualification reports and conducted investigation of deviations.

Mar 2007–Nov 2007 QualComp (Respironics, Inc) Murrysville, PA Consultant, Sr. Quality Engineer

Responsible to develop and implement effective design control system for multi-divisional business groups:

• Audited projects and performed gap analysis on design control system procedures.

• Coordinated project plan to improve design control system.

• Developed detailed procedures for design planning, development, transfer, DHF, design reviews, design verification and design validation processes.

• Performed training to different technical areas on the application of design control procedures.

(R&D, Design Assurance, Marketing, Business Development, ME, Software Assurance)

• Developed procedures for Risk Analysis and Risk Management.

Dec 2006–Mar 2007 Day & Zimmermann (Cordis, LLC) San German, PR Consultant, Validation Engineer

Responsible to support installation and validation of device coating systems:

• Developed project plan for qualification of coating systems.

• Coordinated installation and commissioning of utilities in clean room.

• Developed and executed IQ and OQ protocols for coating system and ancillary equipment.

• Developed IOQ reports for each sub-system.

• Developed protocol to validate like-for-like coating equipment.

Jan 2006–Dec 2006 ReComS Group (Cordis, LLC) San German, PR Consultant, Project Manager

Responsible to manage qualification of new materials for product improvement project:

• Planned and coordinated component qualification with different areas, R&D, Technical Operations, Quality Assurance, Sourcing, Analytical Labs and suppliers.

• Developed component specifications and receiving inspection plans for APIs, active pharmaceutical ingredients.

• Performed Gage R&R on inspection test methodology.

• Developed and validated test methods for sampling and identification of liquid/compressed gases.

• Developed supply chain strategy and materials planning for the project.

• Developed strategy for installation and qualification of inspection equipment.

Jan 2002–Sep 2005 Edwards Lifesciences Añasco, PR

Sr Staff Engineer

Provided engineering guidance for multiple assembly and packaging product lines. Managed engineering support to multiple product lines with over 250 standard models. Supervised four process engineers and two technicians. Monitored and improved product line overall performance including customer feedback, cost and quality.

• Implemented corrective actions that contributed to reduce customer complaints 25% every year.

• Generated and reviewed manufacturing documentation, flow-charts, assembly procedures, labeling, drawings, FMEA.

• Generated charts to monitor scrap trends for the different product lines.

• Analyzed product defects and review data trends to solve situations related to optimize quality levels of the processes and products.

• Developed validation protocols and reports for packaging, assembly and product improvement projects, including PLC controlled equipment. Performed design of experiments to develop process parameters for RF equipment.

• Participated in non-conformances/CAPA investigations.

• Interfaced with R&D to assist in new product development and technology transfers. Identified and coordinated redesign activities. Developed and maintained project schedule for product/technology transfers.

• Participated in qualification of packaging materials and assembly components.

• Developed product documentation for international regulatory submissions. Participated in packaging development for custom defined products.

• Incorporated use of Lean manufacturing tools to reduce scrap, increase yield, and drive down cycle-time thru process development.

May 1996–Dec 2001 Edwards Lifesciences Irvine, CA

R&D Project Engineer

Led development and manufacturing transfer of catheter product projects. Provided engineering guidance for multiple assembly and packaging product lines. Supervised three process engineers and two technicians.

• Led development, validation and transfer to PR of process improvement for CCO catheters.

• Participated in qualification of packaging materials and assembly components.

• Participated in design development and validation of catheter introducer system.

• Supported product transfer implementations at global manufacturing sites together with key improvement initiatives.

• Generated and reviewed manufacturing documentation, flow-charts, assembly procedures, labeling, drawings for compliance to design specifications.

• Developed validation protocols and reports for product/process improvements, including PLC controlled equipment.

• Performed DOE to develop process parameters for RF and PLC controlled equipment.

• Interfaced with manufacturing group to assist in new product development and technology transfers. Identified and coordinated redesign activities. Served as liason between the R&D and PR engineering teams.

• Coordinated fabrication of product for market trials.

• Participated in development of CAPA system for catheter products. Monitored product lines overall performance including customer feedback, cost and quality.

• Participated in Non-Conformance/CAPA investigations. Implemented corrective actions that contributed to reduce customer complaints by 20% in 1999 and 2000.

• Generated charts to monitor scrap trends for the different product lines. Analyzed product defects and review data trends to solve situations related to guarantee optimum quality levels of the processes and products.

• Prepared product documentation for international regulatory submissions.

Dec 1995–May 1996 Venetec International Mission Viejo, CA Product Engineer

Provide engineering guidance to manufacturing operations and product validation. Coordinate manufacturing activities with outside contractors:

• Developed product specifications and validation test methodology.

• Developed and executed product/process qualification protocols.

• Developed 510(k) submission package for products.

• Evaluated alternate suppliers, component and manufacturing configurations.

• Developed semi-automated manufacturing process.

Jan 1995–Nov 1995 Baxter Edwards (Irvine, CA) Mexicali, Mexico Consultant, Project Engineer

Manage manufacturing operations in Mexicali. Supervise assembly line with 27 people, process engineers, materials planner and engineering technicians.

• Assured manufacturing schedule adherence and timely product releases.

• Assured operational quality and FDA/ISO regulatory compliance.

• Served as liason between Irvine team and the Mexicali operations.

• Coordinated R&D activities for new products development.

• Coordinated closing activities and return of capital assets to Irvine.

• Developed and coordinated project plan for qualification activities.

• Developed component specifications, receiving inspection plans for these items.

Jan 1988–Sep 1994 Ohmeda Medical Devices Oxnard, CA Production and Sr. R&D Engineer

Develop medical devices, catheters, delivery systems and accessories integrating with capital equipment. Provide engineering guidance to assembly and packaging of pacing probe and catheter operations. Manage R&D Prototype Lab and fabrication of custom product. Supervise two R&D technicians and 10- 15 assemblers.

• Responsible for training supporting areas for catheter start-up operations in California (engineering, QC, production).

• Developed and validated manufacturing, test and inspection procedures.

• Generated product documentation assembly drawings, manufacturing and test procedures.

• Developed product specifications for Class II and Class III devices and accessories.

• Developed and validated product test methodology for Class II and Class III devices.

• Coordinated development and validation of packaging configurations for multiple catheters.

• Developed and executed product re-validation protocols and reports for different catheters, delivery systems, cables and accessories.

• Managed fabrication and documentation of prototype, clinical trials and special custom products.

• Transferred catheter and pacing wire products to Singapore.

• Developed custom-defined catheters for Asia-Pacific market.

• Participated in development of 510(k) for new special Class II products.

• Supervised production line with 35 employees (3 months). Adhered to production schedules and volume.

May 1980–Jan 1988 Baxter Edwards Añasco, PR

Industrial, Project and Process Engineer

Provide engineering guidance to assembly and packaging multiple product lines. Led projects to transfer products to PR. Supervised drafting area.

• Led successful transfers of Class II and Class III devices to PR.

• Led release of new products to market.

• Developed and validated improvements to manufacturing process (over $800K).

• Participated in documentation and material review boards.

• Coordinated fabrication of prototypes for new products development.

• Developed manufacturing costing, MRP systems, and integrated manufacturing documentation.

• Conducted audit to corporate documentation system.

Education

Aug 1976–May 1982 University of Puerto Rico Mayaguez, PR Bachelor Degree in Industrial Engineering. (BSIE)

Professional Associations

ASQ, Certified Quality Engineer #56067

RABQSA, ISO 13485 Lead Auditor

CIAPR, Professional Engineering License

Contact this candidate