Fernando Sanchez

Anaheim, CA

(Available for Interview anytime during this week and next week with 24 hours’ notice)

(Flexible to work 1st or 2nd shift any)

Professional Summary:

Holds bachelor’s degree with extensive experience working in Quality Systems/Manufacturing Engineering field holding progressively responsible positions with extensive experience in all phases of plant QA, supplier Onboarding/PPAP/ NCRM. SME in the development and maintenance of quality management systems for Class 1, Class 2 & Class 3 devices, internal and supplier audits.

Holds 10 years of experience working with Medical Device Industry like Phillips, Medtronic Neurovascular & Johnson and Johnson.

Frequently completed non-conformance material reports (NCMR's) and Corrective and Preventive Actions (CAPA's) to investigate malfunctions to identify all potential root causes and implement changes to Work Instructions and Standard Operating Procedures for process improvement. Responsible for quality documentation, in-process deviations, supporting R&D new product development, and serving as Quality SME for change control reviews and audits.

Review CAPA / Complaint Investigations, and Non-Conformance reporting and resolved NCMR related issues in collaboration with manufacturing, engineering, regulatory and other stakeholders.

Lead development team in finding root cause and developing corrective action for nonconformances, customer complaints, CAPAs, and support efforts for systemic improvements of NPI/AQP Processes to reduce New Products Quality Notifications (aka NCMR).

Provide technical support and guidance on new products to internal staff.

Lead development team in finding root cause and developing corrective action for nonconformances, customer complaints, CAPAs, and support efforts for systemic improvements of NPI/AQP Processes to reduce New Products QNs.

Education:

University of Southern California- Los Angeles, CA 2001 to 2003

Pursued Master Program in Regulatory Science (40% completed only)

(Course work: Quality Systems (QSR) and Standards, Intro to Medical Products Regulations; Medical Device Regs; Drugs and Biologics Regs)

California State University- Fullerton Fullerton, CA 1991 to 1997

BA in Business Administration; Concentration in Operations Management

Professional Experience:

Gap from Feb 2023- Present looking for new opportunities.

Phillips-Medisize Costa Mesa (PMCM), Costa Mesa, CA Feb 2018 to Feb 2023

Quality Engineer, New Product Introduction (NPI)

Develop quality plan for new products and product changes including the development of inspection methods, inspection equipment, and inspection frequency.

Frequently completed Non-conformance Material Reports (NCMR's) and Corrective and Preventive Actions (CAPA's) to investigate malfunctions to identify all potential root causes and implement changes to Work Instructions and Standard Operating Procedures for process improvement. Responsible for quality documentation, in-process deviations, supporting R&D new product development, and serving as Quality SME for change control reviews and audits.

Review CAPA / Complaint Investigations, and Non-Conformance reporting and resolved NCMR related issues in collaboration with manufacturing, engineering, regulatory and other stakeholders.

Completed pFMEAs, Control Plans, Test, Method Validation, Verification/Process Validation/Qualification (IQ, OQ, PQ) Plans, in new product development and product changes.

Proficient using Minitab 18-20 for Design of Experiments (DOE), Cpk, Ppk, tolerance intervals, ANOVA, ASQ Z1.4 & Z1.9 Sampling.

Perform statistical analysis for the qualification, control, and continuous improvement of processes and product changes. Complete customer required PPAP documentation relating to customer acceptance of new raw material, components products and product changes.

Work with Supplier onboarding, assessment, PPAP (Production Part Approval Process) of raw material components and accessories.

Lead development team in finding root cause and developing corrective action for nonconformances, customer complaints, CAPAs, and support efforts for systemic improvements of NPI/AQP Processes to reduce New Products Quality Notifications (aka NCMR).

Provide technical support and guidance on new products to internal staff.

Lead development team in finding root cause and developing corrective action for nonconformances, customer complaints, CAPAs, and support efforts for systemic improvements of NPI/AQP Processes to reduce New Products QNs.

Understand, support, and contribute to current KOCH-Molex Total Quality Management (TQM), Six Sigma, International Standards Organization (ISO) and Environmental, and/or Health and Safety (EH&S) Management Systems by following stated policies and procedures.

Perform other related duties as assigned by management.

Phillips-Medisize Costa Mesa- Costa Mesa, CA Nov 2017 to Feb 2018

Quality Systems Engineer

Worked with process owners such as procurement, operations, and quality to drive updates to the QMS. Maintained & updated QMS compliance metrics. Scribed FDA audit in May 2018, and set-up Backroom.

Audited QMS to drive compliance, process standardization, waste elimination, and continuous improvement. Monitored, communicated, and improved key QMS KPI’s, including Internal and Customer Audit results.

Wrote and updated QMS procedures to ISO requirements and cGMP regulations based on schedule.

Worked with corporate and other Molex/Phillips-Medisize manufacturing sites to align QMS throughout.

Medtronic Neurovascular- Irvine, CA May 2017 to Nov 2017

Quality System Specialist

Assisted Site with MDSAP audit prep activities. Worked with Department Heads & answered questions related to international MDSAP compliance program.

Lead improvement efforts in the change, approval and release of product documentation and data using PLM/Enovia.

Responsible for developing and maintaining the Corrective/Preventive Action, Nonconforming Material Review, and Returned Materials Systems.

Designed/managed Rework/Revaluation program, Non-Conformance Reporting System, CAPA, IMTE Calibration.

Responsible for developing and maintaining the Corrective/Preventive Action, Nonconforming Material Review System, and Returned Materials Systems.

Submitted monthly reporting of Key Performance Indicators for CAPAs, Material Rejection Notices (MRN)s, Audit findings.

Developed and maintained the Corrective/Preventive Action (CAPA), Material Review Board (MRB), and Complaint Handling.

Updated process flows performed manufacturing & document archiving.

Evaluated & recommended changes to current QMS. Served on cross-functional teams to evaluate system changes/upgrades.

Supported the development & implementation of Quality System procedures, Quality System software List, and Quality System training programs.

Provided expert guidance in interpreting governmental regulations, agency guidelines and Medtronic internal policies.

Employed RCA methodologies (e.g., fishbone diagram, DMAIC, etc.).

Supported internal & external audits/inspections.

Performed other related duties as assigned.

SigmaGraft, Inc.- Fullerton, CA Dec 2016 to May 2017

Manager of Quality & Regulatory Affairs

Established, implemented, and maintained total quality management system including developing quality procedures, implementing quality training, and communicating the results of efforts for the division.

Provided regular status updates and activity reports. (CE Technical Files, Design Dossiers, APAC, etc.).

Provided medical review and assure compliance with promotional materials in accordance with approved labelling, applicable regulations, and industry standards.

Provided strategic direction and advice to project team regarding regulatory pathways and timelines for new and changed products/processes.

Ensured compliance with Quality System requirements, national and international standards, and legislation. Managed and maintained controls and documentation relating to QMS. Performed data gathering, analysis, and distribution of all quality related data and facilitated in identifying improvement opportunities and managed projects through completion.

Maintained and organized the company’s internal quality audit program and managing corrective and preventive action plans. Managed the Internal/ External Audit process with internal customers and third party’s certification and regulatory bodies.

Made recommendations, developed action plan, and followed up to ensure that action plans are effectively implemented.

Conducted internal quality audit of individual department and other group locations.

Assisted department supervisors and managers to evaluate field problem data and develop action plans to prevent cause of problems.

Developed policies and procedures for inspection of various manufactured and purchased products. Analysed/evaluated manufacturing processes to identify improvement opportunities and review new processes for possible integration into systems.

Conducted quality management systems related training. Performed other assigned duties as needed Prepare regulatory submissions to regulatory bodies.

U.S. Technical Advisory Group- Milwaukee, WI Apr 2016 to Dec 2016

Provide comments and recommendations to aid in the development of the U.S. positions on the revision of ISO 19011, attend meetings (i.e., Teleconference, –Face-to-face, and Web conference), review and provide feedback as teams or individually on SharePoint website.

Potential Issues & Enhancements to be considered are Conducting Process Audits within the Context of a MS Audit, Remote Auditing, Communication of Audit Results (Not Just a “Closing Meeting” Anymore), Combined Audits (of Integrated Management Systems), E-Audits (Audits of Electronic “Documented Information”), Selection of Competent Auditors, Link To / Line Between Audit and, Corrective Action Processes, and the need to Retain Independence, Communication & Outreach –Need to Ensure Stakeholders and User Organizations are Aware of Standard and of Revision, Consistency & Alignment with Existing Mgmt. Sys Stds (MSS) Standards & Annex SL, Tie Guidance to Audit Requirements in Existing MSS, Practicality & Usability to Variety of Users (e.g. SMEs), Applicability to Range of Audit Situations (internal, supply chain, other business partners, regulators), Leverage Existing Knowledge & Expertise (e.g. IAF Guides), Time Period for Revision –24 months.

Johnson and Johnson (JJ) Corporation- Irvine, CA Mar 2015 to Dec 2016

Senior Compliance Auditor, JJ Regulatory Compliance

Responsible for the management of the internal quality auditing process and assessment of the company’s activities to verify quality system compliance. Collaborate with business partners to ensure compliance to all regulatory and standard requirements.

Specific areas of focus: Establish, evaluate, and maintain the internal audit program that ensures quality management systems are operating in compliance; develop and manage audit plans; conduct audits, develop metrics, and compile data on auditing results, issues or trends and corrective actions and present to senior management; and develop and deliver required training.

Research emerging regulatory trends and changes in regulations and standards to incorporate into the business to ensure ongoing compliance to these requirements.

Coordinate and support requests for directed audits, received from senior management and other customer/business partner groups; support inspection readiness, external inspections, and other quality and compliance projects; and perform other assigned duties, as needed. Inspection Readiness Team Member as Scribe, Document/Record Reviewer, and Coach to different SMEs prior to interviews with regulatory inspectors.

Masimo Corporation- Irvine, CA Feb 2014 to Mar 2015

Compliance Auditor/SME

Conduct internal QMS audits in compliance with FDA and global regulatory requirements. Responsible for the evaluation of product and quality system documentation, comprehensive document evaluation, overall project planning, execution, and follow-up, revising documents as needed.

Facilitator of RCA/failure investigations and Action Plans, and Effectiveness Checks with CAPA owners. Responsible for identifying the scope of projects related to the comprehensive review of documents that are in place to describe product designs, testing results, quality system generated records and ensuring that the documents meet and exceed the basic requirements of meeting applicable regulations and standards.

Work with departments, responsible document owners to resolve identified issues, provide recommendations and overseeing the corrective action process for identified deficiencies.

Depuy-Synthes Power Tools - Johnson & Johnson Co.- Palm Beach Gardens, FL Aug 2013 to Dec 2013

CAPA Remediation Coordinator (for Oxford Global Resources Client under FDA Global Remediation Quality Plan) Quality Systems/Compliance Subject Matter Expert (SME)

Coordinate all activities through CAPA closure related to the legacy review of CAPAs & product complaints issued against various quality management system (QMS) subsystems to meet FDA deadlines as committed in GRQP plan; Proficient in EtQ Instinct™ system; Meet with CAPA owners or designee and conduct root cause analysis activities; Work with all QS systems (e.g., Legacy CAPAs, Complaints, QSR, Design Controls); Coordination and attendance to CAPA Global Remediation projects; Take direction from local managers as well as managers offsite; Provide CAPA system gap analysis; conducted CAPA and QSR Training, as needed; Work with SME to collect knowledge and work on specified scope; assist in CAPA trending and monitoring. Proficient in using EtQ Instinct™ system and SAP for CAPA file processing and closure.

Certifications:

American Society of Quality (ASQ)- Milwaukee, WI- 1995 to Present

Certified Six Sigma Black Belt (CSSBB) Dec. 2009 (Cert. No. 7849)

Certified Quality Manager (CQM) – Oct. 2000 (Cert. No. 05438)

Certified Quality Engineer (CQE) – Dec. 1999 (Cert. No. 39888)

Certified Quality Auditor (CQA) – Dec. 1995 (Cert. No. 13975)

Seminars: Risk Mgmt, Clinical Trials, FDA Open House Meetings, Process Validation, Six Sigma, CQA-Biomedical

Regulatory Affairs Professional Society (RAPS)- Rockville, MD- 2002 to Present

U.S. & E.U Regulatory Affairs Certification (RAC) (Nov.’02, ‘03), Mgmt Rep. training (Jan. ‘03)

Educational Conference (Mar.’03)

British Standards Institute (BSI)- Washington, DC- 2010 & 2003

Quality Management Systems & Environmental Management System RAB-QSA Lead Assessor Training, Implementing ISO 13485:2003

Orange County Regulatory Affairs- Irvine, CA- 1999 to Present

Seminars: CAPA, Recalls and QSIT Inspections, Update on Biocompatibility Testing Requirements, FDA Inspections,

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