OBJECTIVE:

• Senior Quality Engineering, Subject Matter Expert (SME) on Sterilization and Environment Controls or in a related Field
• Opportunity to make a positive impact throughout the organization and throughout the company, for achieving departmental goals and time lines, as well as meeting the customers’ expectations and objectives for products and systems being provided.

SUMMARY:

• Passionate, diligent and results oriented Senior Quality Engineer, strong background in sterilization processes related to the development of documents to transfer into a mature production phase with all proper compliances to all ISO standards.
• Lead by example, with tremendous drive and vision, appetite for getting things done & strong “hands on” work ethic.
• Experience with sterilization process controls that implement Risk Analysis, DOE, FMEA’s, ISO, Spec’s & trend analysis.
• Represent Quality Engineering during New Product Development, (NPD) for Design Control for review & approval of the applicable Design Input, Design Output, Design Verification, Design Validation during the transfer of R&D phases.
• Making improvements to Quality Assurance (QA), Parts Inspection Plans (PIP’s), Quality Inspection Procedures (QIPs), Manufacturing Work Instructions (MWI’s), Validation Test Protocols and Test Reports. Updates to the following; Device Master Record (DMR), Device History Recodes (DHR) & Design History Files (DHF) per FDA 21 CFR 820.30, ISO 13485 7.3.2, ISO 11135, ISO 11137, ISO 11737, ISO 14644, IEC/ISO 62366, EN IEC 60601 - 1, EN ISO 14971 & IEC 62304.
• A well-established senior-level medical device professional with 15 years dealing with a highly regulatory industry for domestic and international industries, in both early stage development as well as well established multi-billion-dollar medical leaders. Consistently meeting demanding timelines, organizational goals & objectives to meet project needs.
• Experienced in concept R&D prototype clinical trials development environments used in lab study product testing for medical devices in small to large Electrical Mechanical Assemblies. Well versed in Project Management and Cross Functional Project Leadership. Have an excellent record of taking products from conception to market release with successful product launches and commercialization, meeting all FDA risk management medical devises requirements.
• Open mind on diagnostic issues that encompass a great deal of versatility, flexibility related to product safety & reliability.
• Hands on involvement in directing, developing, implementing, monitoring, supporting internal and external auditing.
• As the Senior SME Quality Engineer, I would ensure the design outputs are adequate to fulfil the input requirements. That acceptance criteria as defined for outputs essentials are properly documented for the device being modified in JDE.

PROFESSIONAL EXPERIENCE:

Confidential, San Diego, Ca

Senior Quality Sterilization Engineer

Responsibilities:

• Spearheaded projects that resulted in avoiding major observation before becoming issues for the quality department.
• A complete and major overhaul was necessary to the entire sterilization system, having to rewrite each individual document related to product sterility, process improvements being performed to all the sterilization functions related to; Gamma Dose, Bioburden testing, Manufacturing, Packaging, Labeling, Product Inspections, Devices Master Record (DMR’s), Devices History Record (DHR’s) with notable results accomplished to alignment us with all ISO standards.
• Addressed areas that were not being executed properly for the past 2 years ( ), related to Periodic Quarterly Bioburden testing for each quarter for VD Max Dose Audits reviews, “Annual reviews” for; CFU Bioburden Annual reviews, Product Family Reviews for notable changes to product sterilization, Product Stability Reviews on the four (4) year shelf life, Environmental Control Reviews of the process related to gowning room and the manufacturing room for all sterilized products manufactured and packaged during the pre and post process for sterilized products.
• Replaced current dunnage used for processing sterilized loads that was not a good representation of actual product.
• Resolved sterilization load issues relating to weight, density and penetration to process maps performed by sterilizer.
• No audit finding during my time in this position, was involved in over 5 audits, with FDA, BSI, and 3 overseas agencies.

Confidential, Ann Arbor MI

Senior Quality Production Engineer

Responsibilities:

• Assist in Terumo’s Consent Decree Remediation, Interface with front line support to Quintiles for FDA preparation.
• Technical guidance on preparation of Lab Studies (LS), verification reviews on over 188 LS in a six months’ period.
• Addressed 97 observation responses from Quintiles with a 100% acceptance for correctly resolving related issues.
• Outside Auditors “Final” mockup FDA audit review resulted in “0” observation & “0” opportunity for improvements.
• Identifying return products from customers, identifying issues related to returns and why it was returned, along with ensuring that the materials is being addressed for containment, quarantine, investigation, root cause, cause and effect, rational, impact assessment, corrective & preventive action and verification of closure to all actions completed.
• Facilitated actives in process improvements on Parts Inspection Plans (PIP’s), Quality Inspection Procedures (QIPs).
• ECR’s, Engineering Change Request - on corrective action and preventive action of any NCR’s. Initiating correction to affected documentation & initiating the ECO to correct the problem to comply with Risk Management EN ISO 14971.
• Active role in project level documentation for design tracing confirmation verification of validated evidence of documents presented for test requirements for auditing purpose - down streaming documentation to investigate disconnect from deliverable report to actual representation & status of the process at the time of final test validation.
• Daily activities working on: CO’s, CC’s, NCR’s, SCAR’s, CAPA’s Observations, ongoing troubleshooting investigation analysis on product issues, review of sterile loads to release to FG, internal and external audits with TUV and FDA.
• Working with R&D, and Manufacturing Engineering to ensure newly developed products are properly transferred into newly production development phase in compliance with all applicable requirements from cradle to grave. Meeting all requirements for 21 CFR 820 (Quality System Requirements), EN ISO 13485:2003, EN ISO 14971:2012, and CGMP.
• Team leader supporting production and design change of complex electronic medical devices along with a cross functional groups for continuing engineering process for products that have transferred to commercial production.
• Address nonconforming issues, find best suitable solutions, resolve containment & drive corrective/preventive actions.

Confidential, Irvine, CA

Quality Assurance / Sterile Products Engineer

Responsibilities:

• R&D product development - Point of contact for phase design inputs and outputs, identifying product design inputs requirements into product design requirements, specifications, through translation of accepted needs from various sources including feedback from users, Confidential ts & stakeholders to the design & development implementation groups.
• Provide R&D stakeholders design outputs suitability reviews for Per-Market Engineering, Post-Marketing Engineering, Design Assessment Group, Materials Management, Supplier Quality, Operations Management & Manufacturing Eng.
• Design Assessments on in-vitro diagnostic systems, Per-Market Engineering, Post-Marketing Engineering evaluations.
• Reviewed & provided technical support on design transfer using IQ, OQ, PQ, Test Method Validation (TMV) Processes.
• Up and downstream of documents requiring investigations and verification for assembly and testing requirements.
• Provide technical support to Manufacturing Engineering team on IQ, OQ, PQ, V&V on new cables & sensors projects.
• From the R&D phase to the Production phases, assisted design engineering and manufacturing engineers with the production transferring to a fully developed ready to release production to the manufacturing facility in Mexicali Mexico.
• Design Verification planning, reporting results that show the product design outputs meets design requirements.
• Design Validation, traceability from design inputs though specifications for design outputs and evidence of results.
• Review design changes on documentation during development prior to commercialization phase release activities.
• With the help of the Program Manager and the Manufacturing Engineer, as the Quality Engineer, I would help define the R&D inputs and outputs for tasks required for transferring the newly design prototype project to the pilot production release phase with all the proper processes and procedures. Ensuring that the transfer is properly being transferred with complied with all records for operators and inspectors and that all test validations are in place for the electronic products that will be develop within the timelines, production assign tasks and track progress.
• Responsible for all aspects of sterilization process validation, improvements & documentation in place per ISO 11135.
• DHF, Design History Files, managed and maintained ongoing engineering changes and design review phase closures.
• Project Development phase for Phase I, Concept, Phase II, Feasibility, Phase III, Development, Phase IV, Scale up to Launch into Production readiness, Phase V, Ready for Commercialization for sales, and Phase VI, Market Acceptance.
• Daily activities working on: CO’s, CC’s, NCR’s, SCAR’s, CAPA’s Observations, ongoing troubleshooting investigation analysis on product issues, review of sterile loads to release to FG, support internal & external audits with TUV & FDA.

Confidential, San Diego, CA

Responsibilities:

• Provided day-to-day guidance and direction to equipment operators, manufacturing production line, test personnel, production team leaders, procurement, quality, shipping & receiving & all essential associated management for ATO.
• Responsible for being the trouble-shooter on the production floor and through all phases of the manufacturing process for product readiness and transfer to a mature product line, using Critical to Quality (CTQ), Risk Assessment Metrics (RAM), Failure Analysis Investigation (FAI), Value Stream Mapping (VSM) and Fishbone Diagrams processing.
• Performing the following inspection planning requirement for scheduling testing and qualifications requirements and release of design change for Quality to released products, as required during the life cycle of commercialized devices.
• Represented Quality Assurance during the Design Control and Design Review process through review and approval of the applicable Design Input, Design Output, Design Verification, Validation and Design Transfer during the R&D phase.
• Q.E. supervisor on special projects for new and existing product lines, making decisions in a timely manner based on analysis of change, past history, production priorities, impact to customers, cost, and schedules and mgmt. approvals.
• Acceptance of sampling plans studies, data analysis, touch labor, work schedules, materials and equipment, using work order processing with inventory control requirements in ERP, MRP, BOM, with Expandable Oracle, Agile, Avant.

Confidential, Huntington Beach, CA

Sr. Mfg. Engineer

Responsibilities:

• Project lead for outside vendor’s section & validation process, worked with machine shops to meet design requirements.