Devin Mcelroy Email & Phone Number

Fresno County, California, United States

Quality System Modelers, LLC (QSM LLC) provides industry-specific models, tools, guidance, frameworks, and methodologies for the establishment or remediation of Quality Management Systems and QMS elements that are fully compliant with medical device, pharmaceutical, and/or biologic manufacturing regulations in the United States including U.S. FDA, ICH, and ISO requirements

Fresno, California Area

Fresno, California Area

Develop, implement and maintain a comprehensive Quality & Regulatory Affairs system in accordance with regulatory/accrediting requirements.• Responsible for the implementation and management/oversight of the quality assurance and quality improvement programs. • Manages, coordinates and administers all functions of the Q&RA function to achieve company compliance and objectives and demonstrate continuous improvement. • Develops and leads a quality and regulatory staff with the skills and abilities to ensure quality products and regulatory compliance for North America. • Oversees Complaints investigation, MDRs, Corrective and Preventive Action (CAPA), HHE/HARM, Supplier Development/Quality and other related processes, including investigations, resolving quality concerns and issues and maintaining all required documentation.• Manage, and establish / maintain compliance with FDA QSRs and other global regulation as applicable. • As the organization’s official contact/liaison for all regulatory matters, establish and maintain positive relationships with government agencies and other regulatory authorities and represent the organization in matters before such agencies and authorities so that the organization’s goals and objectives are advanced.• Represents the business during any inspection/audit processes, internal or external. Implements appropriate activities to ensure regulatory compliance and adherence to the quality system. • Communicates with all functional groups to ensure awareness of regulatory and quality requirements. Provides and/or coordinates company-wide quality and regulatory training.

Oakland, Ca

Serve multiple clients in the capacity of a QMS expert, internal auditor, and trainer. Identifies gaps in QMS and assists clients in establishing new or more robust quality systems. Assists with filling compliance gaps identified during agency audits. Provides instruction to clients in audit readiness and compliance.Clients Served: Bosch Healthcare, Kettmann Machining, Lawrence Livermore National Laboratory, National Display Systems, Xoft, Cortera Neurotechnologies, and many others.- Established entire Quality Management Systems for clients new to medical devices and completed work to prepare for pre-IDE submissions within U.S. Authored all QMS documents, conducted formal training for organizations on Quality and Regulatory Requirements including QSRs, CAPAs, Risk Management, Design Controls, audit readiness, etc.- Lead Auditor for internal quality audits assessing compliance with 21 CFR 820, ISO 13485, Medical Device Directive (93/42/EEC), Canada Medical Devices Regulation (SOR/98-282), Japan (MHLW MO No. 169), Australia (TGA), etc.- Instrumental in assisting numerous clients in leading efforts to close time-critical CAPAs, NCRs, and Complaints. Trained numerous clients on industry-standard practices for CAPA, NCR, Complaint, Design Control, and Risk Management programs- Led numerous clients on efforts to establish internal quality system programs (e.g., compliance readiness, CAPA programs including NCRs and SCARs, Post-Marketing Complaint Management Programs, Design Controls, Risk Management, etc.)

Fremont, Ca

Perform Root Cause Analysis investigations of post-market product complaints and provide Quality Engineering expertise for new product development projects. Liase with multiple departments including, but not limited to Engineering, Regulatory, Quality, Design/Development, Research and Development, Manufacturing, and Supplier Management. * Created and implemented new process for U.S. Complaint Investigations Site. Decreased reworks from 75% to 35%.* Provided Quality Engineering leadership and expertise on New Product Development teams* Provided leadership for U.S. Complaint Investigation personnel over multiple sites (U.S. and Japan)

Cleveland, Ohio

Manage complex product and process investigations, evaluate data, carry out root cause analysis, implement and monitor corrective actions through proof of effectiveness. Meet with large cross-functional teams representing all company interests including, but not limited to Engineering, Regulatory, Quality, R&D, Manufacturing, and Supplier Management.* Instrumental in assisting in bringing 70 aging CAPAs to closure in four months; many were regulatory commitments* Led cross-functional teams for participation in root cause analysis, CAPA Development, and Corrective Action implementation

Corona, Ca

Manage complex product investigations, evaluating data, carrying out root cause analysis, and devising corrective actions. Design proposals and author investigation summaries on an ongoing basis. Initiate CAPAs resulting from Product Investigations. Lead all phases of product investigations from inception to closure; assess and report quality data and complaint trends to senior leadership for use in Management Reviews; and direct Quality Investigation teams for complaint response and nonconforming products.* Instrumental in bringing 100 critical product investigations to closure.* Led desktop audits to ensure compliance with all regulations as well as internal procedures and controls.

San Jose, Ca

Manage complex product investigations, evaluating data, carrying out root cause analysis, and devising corrective actions. Design proposals and author investigation summaries on an ongoing basis. Initiate CAPAs resulting from Product Investigations. Lead all phases of product investigations from inception to closure; assess and report quality data and complaint trends to senior leadership for use in Management Reviews; and direct Quality Investigation teams for complaint response and nonconforming products.* Instrumental in bringing 100 critical product investigations to closure.* Led desktop audits to ensure compliance with all regulations as well as internal procedures and controls.

Rancho Cordova, Ca

Oversaw key finished goods nonconformance reports (NCMRs), critically supporting the company’s Corrective and Preventive Action (CAPA) program. Captained internal improvement projects, conducting extensive root cause analysis to eliminate inefficiencies and mitigate risk. Rolled-out formal training program to support staff development. * Reduced backlog of NCMRs by 50% and CAPAs by 30% and created core QSR training materials for 2011.* Established new C of C program and authored all documents and training materials to ensure successful launch.

Temecula, Ca

Leveraged broad-scope regulatory compliance expertise to spearhead Compliance Enhancement Projects across multiple areas of internal operations. Planned and led far-reaching internal audits to evaluate compliance-readiness organization-wide.* Identified key risk areas and led successful mitigation projects, overseeing process consolidation and gap identification to ensure comprehensive compliance with all relevant regulatory guidelines/frameworks.

Valencia, Ca

Built and maintained key programs to enhance Supplier Management and establish Internal Quality Auditing program. Introduced and evolved Quality strategies, captained planning activities, and performed broad-scope risk management. Participated in FDA and Notified Body inspections/audits as Quality representative for Supplier Quality and Quality Compliance programs. Conducted Internal Quality/Supplier Audits; carried out in-depth root cause analysis of nonconformances; and participated on FDA response teams responsible for authoring responses to FDA findings* Reduced overall supplier audit backlog by 75% and personally authored new risk analysis plans to support a new product. * Rolled-out new Internal Audit Program and drafted supporting documentation to ensure regulatory compliance. * Provided operations-critical Quality oversight in animal laboratory testing to ensure compliance with GCPs and GLPs.* Recognized QA subject matter expert (SME) across new product design and process improvement projects.

Sunnyvale, Ca

Performed internal quality audits assessing compliance with all applicable regulations while overseeing Internal Quality Auditing Program and training new internal auditors. Participated in FDA and inspections, serving as Quality representative for Internal Compliance program* Reduced internal audit backlog by 100% while assessing compliance to all applicable regulations.* Ensured completion of all project requirements by contract end-date.

Sunnyvale, Ca

Managed Corrective and Preventive Action (CAPA) program while ensuring compliance with internal procedures and relevant regulatory guidelines. Created and maintained all Quality Systems, including Inspection Readiness and Supplier Qualification. Compiled and presented quality scorecards at Management Review meetings on an ongoing basis. Hosted FDA and Notified Body inspections/audits, directly interfacing with FDA inspectors and Notified Body auditors.* Closed 98% of all CAPAs within 30 days.* Liaised with the FDA and proactively managed audits to achieve flawless track record during tenure—0 warning letters/major nonconformances.* Completed Technical Design Dossier for European submission and CE Mark.

Prepared 510(k) submission for new Class II Medical Device. Led research projects for substantial equivalence and conformity.* Initiated and completed complex 510(k) submission for Class II device a full 2 weeks ahead of schedule

South San Francisco, Ca

Managed both the Change Control and Technical Publications departments, leading new-process implementation plans while overseeing all aspects of product qualification and risk management in daily operations.* Led the process improvement teams that improved change management throughput by >400%.* Reduced variation within change control processes by ~50% through superior management practices.* Tapped to serve as Operational Excellence Project Leader and led ongoing risk management/mitigation projects.

Pleasanton, Ca

Job Titles/Duties• Contract Technical Writer (software manuals)• Software Development Associate (code reviews and bug reports)• Technical Publications Manager (managed two sites)Firms• Resumix, Inc. – Sunnyvale, CA• Kaiser Permanente, Inc. – Oakland, CA• Concord EFS – Pleasanton, CA

Milpitas, Ca

Job Duties• Managed Quality software development projects• Captured and documented software concept documents; software, design, interface, and user requirements; software and interface specifications; code review reports, and software risk analysis reports• Submitted proposed design changes to Research & Development• Wrote operating procedures, work instructions, and guidelines for quality system management• Supervised contract Technical Writers and Systems AnalystsAccomplishments• Completed 100% of software lifecycle development documents within required timeframe (included requirements, specifications, testing, analysis, and summary reports)• Provided quality oversight in software development lifecycle ensuring all documentation was completed or absence adequately justified

Chico, Ca

Job Duties• Manage company conformance with regulatory requirements including FDA, OSHA, and local business regulations• Wrote software technical manuals for medical device software product• Perform black box testing on software product• Managed Packaging/Labeling and Shipping/ Distribution departments (up to 12 employees)Accomplishments• Wrote 510(k), accepted on first submission• Established document change control program including procedures and site-wide formal training• Assisted in the establishment of the change control program for the company’s medical device software product (Prowess 2000)• Assisted in the establishment of a quality department• Assisted and Hosted FDA inspections. Worked with FDA on establishment of software-related guidance initiatives including implementation of software development lifecycle and testing protocols

Mba, Technology Management

B.S., Business Information Systems