Quality Assurance Medical Device

John E. Taylor 214-***-**** cell • ***********@*******.*** • LinkedIn Profile

Quality Assurance Engineer

Driving Excellence in Medical Device Manufacturing through Strategic Quality Systems and Regulatory Compliance Experienced Senior Supplier Quality Engineer with a proven 20+ year track record of excellence in the medical device manufacturing industry. Highly skilled leader in developing and implementing comprehensive quality systems, with expertise in FDA/ISO regulations and completing over 600 supplier audits across US and European facilities. Strategic change agent recognized for building and leading quality teams while driving continuous improvement initiatives that have achieved up to 77% cost reductions and 50% yield rate improvement in critical manufacturing processes. Demonstrates exceptional ability to collaborate across engineering, regulatory, and production teams to ensure compliance while optimizing supplier performance and product quality throughout the product lifecycle. Areas of Expertise

Quality Certifications & Standards: Senior Lead Auditor (600+ Audits) - CFR 820-ISO-13485-EU MDR - FDA 21 CFR Compliance - ISO 17025 - ISO 14971 - ISO 9001 - Quality Assurance - FMEA/CAPA - Kaizen & SPC/SQC - Gage R&R - Statistical Process Control - First Article Inspection - Gap Assessment - Incoming Quality Assurance

Technical Expertise: GD&T Dimensioning - Injection Molding/Tool Maker - Part Design - Process Capability Studies - Material Selection - Configuration Management - Ship-to-Stock Program Implementation - Lean Manufacturing - Value Stream Mapping - Cost Estimation - Electrical Engineering - Testing Protocols - Tooling Specifications

Development & Management: New Product Development - Supplier Management - Cross-Functional Team Leadership - Crucial Conversations - Six Sigma - Project Management - Contract Review - Design Control - Compliance Management - Procurement Documentation - Contract Review Optimization - Operational Function - Safety Stock Management

Regulatory & Documentation: Biologic Med-Device IDE Package Submission - Process Documentation - Engineering Change Management - Manufacturing Technology - Product Realization - Process Development - Process Controls - Production Engineering

- Yield Improvement - Tool Design

Executive Career Progression

Network Partners 2021-10/2024

Senior Quality Consultant (Remote)

• Examined quality management systems and authored comprehensive gap assessments to drive successful CFR and ISO 13485 registration initiatives across multiple client organizations.

• Led quality engineering teams to resolve multiple aging 483 CAPAs, ensuring full compliance with CFR requirements and EU MDR regulations.

• Partnered with Subject Matter Experts and Quality Engineers to coordinate and deliver timely responses to critical regulatory action items.

• Collaborated with Engineering and Regulatory teams to develop and submit a biologic Medical Device IDE package, securing FDA approval.

Orthofix Corporation, Lewisville, TX 2010-2021

Senior Supplier Development Engineer

Established and implemented a comprehensive Supplier Quality Department, developing robust procedures and documentation systems to demonstrate regulatory compliance. Provided strategic technical leadership across all quality engineering functions throughout the product lifecycle, from conception to customer implementation. Managed concurrent quality initiatives for multiple product development projects, ensuring alignment with quality standards and regulatory requirements throughout the product realization process.

• Executed comprehensive supplier audits across US and European facilities, managing critical CAPA implementation and maintaining rigorous documentation of supplier quality records with a 100% compliance rate.

• Spearheaded the development of a robust Supplier Quality Management system, implementing standardized procedures aligned with 21 CFR parts 11, 201-211, 820, 1271, 1272, ISO-13485, ISO 9001, and ISO 14971 regulatory requirements.

• Drove strategic supplier improvement initiatives encompassing CAPA management, inspection protocol enhancement, contract review optimization, ship-to-stock program implementation, and design control advancement to elevate supplier performance standards.

• Led cross-functional review of design specifications, manufacturing processes, procurement documentation, and testing protocols, ensuring strict adherence to division and customer quality requirements across all assigned products and programs.

• Fostered collaborative partnerships with design engineering, manufacturing, purchasing, and production teams, delivering integrated quality assurance solutions while maintaining alignment with Compliance and Quality Assurance objectives.

• Pioneered innovative Ship-to-Stock program implementation, leveraging lean methodologies through value stream mapping and statistical process control, achieving a 20% reduction in internal and external operational costs. OsteoMed Corporation, Addison, TX 2009-2010

Senior Quality Engineer

Provided comprehensive quality assurance leadership for assigned programs, ensuring products met rigorous customer and divisional quality requirements throughout design, procurement, and manufacturing processes. Developed and implemented new quality systems and procedures, driving continuous improvement initiatives across quality-related activities.

• Performed comprehensive reviews of design, manufacturing, purchasing, and test documentation across product lines to ensure fulfillment of divisional and customer quality requirements.

• Delivered strategic recommendations to management for process and procedural improvements in configuration management and operational functions.

• Spearheaded quality and supplier quality engineering for the company's largest product launch, achieving enhanced timeline efficiency and improved first-pass yield.

• Mentored engineering teams on implementing Geometric Dimensioning and Tolerancing (GD&T), ensuring design requirements maintained product integrity.

Abbott Laboratories, Irving, TX 1999-2009

Senior Supplier Quality Engineer (2001-2004 & 2006-2008) Incoming Quality Assurance Section Manager (2004-2006) Tooling & Design Engineer (1999-2001)

Led national and international supplier audits, ensuring FDA and ISO compliance. Provided technical guidance for medical device design, including cost estimates and material selections. Managed CAPA initiatives and conducted Gage R&R studies to ensure product manufacturability. Directed Incoming Quality Assurance operations, leading a 14-member Inspection team. Resolved complex manufacturing challenges at supplier sites to drive business growth and profitability.

• Led cross-functional product design teams, managing comprehensive development from part and tooling design through material selection, process capability, Gage R&R, and inspection protocols.

• Transformed critical injection mold performance with four core pulls, three unscrewing cores, and a slide, improving yield rate from 50% to 98%, resulting in a 45% cost reduction per part.

• Orchestrated transfer of 100+ tools to three new suppliers, managing timelines, budgets, safety stock, first articles, engineering changes, process capability, and Gage R&R studies.

• Achieved a 37% productivity increase by developing and implementing new incoming quality assurance and First Article Inspection procedures, including the ship-to-stock program.

• Resolved critical assembly manufacturing issues ahead of schedule, ensuring the timely launch of the new instrument platform.

• Delivered 77% part cost reduction through identifying and implementing innovative manufacturing technology. Education

American Intercontinental University, Bachelor of Business Administration (BBA)

• Double Major: Management and Marketing

• Graduated Cum Laude

Professional Development & Certifications

Regulatory & Quality Systems

• FDA 21 CFR Parts 11, 21, 801, 803, 806, 820, 822, 1270, 1271, 11135, 11137

• ISO 13485, 9001, 14971, 17025

• ISO Lead Auditor Certification

• IPC-A-610, IPC-A-620, and IPC-A-640

Technical Expertise

• Statistical Process Control (SPC)

• Geometric Dimensioning & Tolerancing (GD&T)

• Class A Injection Mold Builder Certification

• Laser Sintering

Leadership & Process Improvement

• Six Sigma Certification

• Abbott Leadership Program

• Crucial Conversations

• Integrity Selling

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