William Taylor
Summary
Dynamic Senior Quality Engineer with over 20 years of extensive experience leading quality efficiency initiatives and driving process improvement across diverse manufacturing environments. Renowned for expertly implementing stringent quality control measures, conducting meticulous root cause analyses, and ensuring steadfast compliance with industry standards. Demonstrated proficiency in fostering the growth and development of high-performance teams to consistently surpass organizational objectives. Eagerly seeking a challenging opportunity to leverage my wealth of experience and contribute to the success of a forward-thinking organization committed to excellence and innovation.
Overview
19
19
years of professional experience
1
1
Certification
Work History
Senior Quality Engineer (Interim Quality Manager)
Integra Life Science
05.2021 - Current
- Mentored junior engineers on best practices in quality engineering, fostering a culture of excellence within the team.
- Facilitated process improvements to successfully decrease errors, saving the company ______ millions.
- Controlled resources and assets for department activities to comply with industry standards and government regulations.
- Fostered an environment that encouraged open dialogue regarding process improvements, leading to higher employee engagement levels in quality initiatives.
- Created detailed reports on engineering activities and findings.
- Developed and implemented comprehensive quality assurance program to guarantee organization products met safety and quality standards.
- Optimized inspection methods for decreased downtime while maintaining strict adherence to quality requirements.
- Led engineering teams to successfully complete projects on time and within budget.
- Designed and implemented quality control processes to facilitate customer satisfaction.
- Exercised leadership capabilities by successfully motivating and inspiring others.
- Drove standardization efforts across multiple production lines to ensure consistent product output meeting stringent specifications.
- Provided technical support in resolving complex quality issues by conducting thorough investigations and presenting data-driven recommendations.
- Certified Internal Auditor: Plan and execute internal audits against relevant quality system standards, regulations and internal procedures to ensure compliance.
- Drive product safety through authorizing/approving of risk management plans, collaboration with Medical Affairs, and mentoring engineers on system risks assessments and Failure Mode and Effects Analysis (FMEA).
- Provided guidance on the selection of statistical analyses and sample sizes for verification, validation, and other qualification and acceptance testing.
- Executed meticulous validations on cutting-edge manufacturing equipment, ensuring seamless integration into operations and minimizing downtime.
- Drove substantial improvements in production throughput by applying LEAN Six Sigma methodologies, enhancing efficiency, error proofing, and reducing waste.
- Provided strategic direction and valuable guidance to peers and junior engineers, leveraging years of hands on production experience and adherence to Standard Operating Procedures (SOP).
- Devised an implemented plans for maximizing the utilization of internal personnel, aligning workforce capabilities with organizational goals for optimal efficiency.
- Managed and coached a team of 7 employees, providing guidance, mentorship, and support to foster individual growth and enhance overall team performance.
- Conducted thorough audits of manufacturing processes and quality management systems to ensure compliance with the new EU Medical Device Regulation (MDR) standards, facilitating a smooth transition for Integra's products.
- Collaborated with cross-functional teams to assess the impact of the new EU MDR requirements on existing processes and procedures, identifying gaps and implementing corrective actions to achieve compliance.
- Provided training and guidance to internal stakeholders on the requirements of the EU MDR, including changes in classification, labeling, and post-market surveillance, to ensure awareness and understanding across the organization.
- Established and maintained a robust internal audit program to monitor compliance with the EU MDR requirements and identify opportunities for improvement, driving continuous compliance efforts.
- Coordinated external audits by notified bodies to assess compliance with the EU MDR requirements, providing documentation and support to demonstrate adherence to regulatory standards.
- Facilitated communication and collaboration with regulatory authorities and notified bodies to address questions and requests for information related to compliance with the EU MDR, ensuring transparency and responsiveness in regulatory interactions.
- Facilitated communication and collaboration with regulatory authorities and notified bodies to address questions and requests for information related to compliance with the EU MDR, ensuring transparency and responsiveness in regulatory interactions.
- Implemented risk management strategies, including the application of ISO 14971 principles, to assess and mitigate risks associated with non-compliance with the EU MDR requirements, ensuring product safety and efficacy.
- Maintained awareness of changes and updates to the EU MDR requirements and regulatory landscape, proactively adapting compliance strategies and procedures to remain current and responsive to regulatory expectations.
- Collaborated with external consultants and legal experts as needed to interpret and implement the requirements of the EU MDR, ensuring accuracy and completeness in compliance efforts while minimizing business impact.
Quality Assurance Manager
LeachGarner
05.2018 - 05.2021
- Directed and mentored a team of 12 members facilitating collaboration and implementing strategies to optimize productivity and goal achievement.
- Managed inspection labs across multiple facilities.
- Lead Hoshin project reducing restart percentage from 6% to 2.5% using failure investigations.
- Evaluated interactions between associates and customers to assess personnel performance.
- Played a crucial role in refining company manufacturing practices by providing expert guidance on regulatory compliance matters.
- Prevented costly recalls by proactively addressing potential risks before they escalated into larger issues.
- Drove successful product launches with rigorous pre-release testing protocols that minimized post-launch issues.
- Collaborated with audit clients and action owners to apply root cause analysis guidance and establish effective corrective action plans.
- Evaluated new technologies and methodologies for potential implementation within the organization''s quality assurance program, staying ahead of industry trends.
- Managed supplier relationships, enforcing strict standards for incoming materials and components to preserve product integrity and minimize rejections.
- Facilitated communication between departments regarding quality concerns, fostering collaboration towards shared goals.
- Championed continuous improvement initiatives, consistently seeking ways to optimize operations for better results.
- Lead ISO Certification Auditor and Trainer for all engineers.
- Here are some additional bullet points for your resume as a Quality Assurance Manager at a Metal Manufacturing facility:
- Implemented Lean Six Sigma methodologies to streamline manufacturing processes, resulting in a 10% reduction in defects and a 15% increase in overall efficiency.
- Spearheaded the development and implementation of a comprehensive quality management system, resulting in a 20% improvement in product quality and customer satisfaction ratings.
- Conducted root cause analysis and implemented corrective actions to address non-conformances, resulting in a 25% reduction in product recalls and rework.
- Established and maintained supplier quality management programs, ensuring compliance with industry standards and reducing supplier defects by 30%.
- Led cross-functional teams in continuous improvement projects, resulting in annual cost savings of $500,000 through process optimization and waste reduction initiatives
- Developed and delivered training programs on quality assurance processes and procedures, ensuring alignment with industry best practices and regulatory requirements.
- Implemented statistical process control (SPC) techniques to monitor and improve manufacturing processes, reducing variation and enhancing product consistency.
- Collaborated with engineering and production teams to identify and resolve quality issues, resulting in a 15% increase in first-pass yield and on-time delivery performance.
- Conducted regular audits and inspections to assess compliance with internal quality standards and external regulations, ensuring adherence to ISO 9001 and other quality management system requirements.
- Championed a culture of continuous improvement and quality excellence, resulting in the achievement of ISO 9001 certification for multiple manufacturing facilities.
Senior Quality Engineer
Interplex
05.2015 - 05.2018
- Streamlined production lines for increased efficiency, reducing defects and minimizing waste.
- Developed and implemented comprehensive quality assurance program to guarantee organization products met safety and quality standards.
- Developed action plan for company certification using ISO 9000 standard knowledge.
- Played a key roll in a cross-functional team focused on scrap reduction, achieving a remarkable decrease from 15% to 5% in monthly scrap while simultaneously increasing throughput by 20%
- Conducted internal, external, and site certification audits, ensuring compliance with industry standards and regulations such as ISO 9001, ISO 13485, and IATF 16949.
- Implemented statistical process control (SPC) methodologies to monitor manufacturing processes and identify opportunities for improvement, resulting in a 15% reduction in defects and enhanced product reliability.
- Developed and implemented quality assurance procedures and work instructions, ensuring alignment with customer specifications and industry standards, which led to a 25% reduction in non-conformances.
- Collaborated with engineering teams to conduct root cause analysis and implement corrective actions for quality issues, resulting in a 30% decrease in customer complaints and an improvement in overall product quality.
- Facilitated supplier quality management initiatives, conducting supplier audits and implementing supplier corrective action plans to address quality issues and improve supplier performance.
- Played a key role in new product development projects, conducting risk assessments and design reviews to ensure product quality and regulatory compliance from concept to commercialization.
- Provided training and mentoring to junior quality engineers, fostering a culture of continuous improvement and knowledge sharing within the quality department.
- Acted as a liaison between customers and internal teams, addressing quality concerns and facilitating resolution to maintain strong customer relationships and enhance customer satisfaction ratings.
Sustaining Quality Engineer
Bridgemedica
01.2005 - 05.2015
- Facilitated training sessions for team members on quality management principles and best practices, enhancing overall competency levels within the department.
- Performed quality inspections and drafted reports to detail non-conforming material issues.
- Evaluated new materials or components for suitability within existing manufacturing processes while considering factors like cost-effectiveness, durability, and functionality of the finished product.
- Developed action plan for company certification using ISO 9000 standard knowledge.
- Established robust documentation systems for tracking product specifications, test results, and change requests in an organized manner.
- Organized and managed Quality Engineering team resources effectively, assigning tasks according to strengths, skill sets, and workload balance for optimal efficiency.
- Developed inspection plans based on design specifications, ensuring all critical dimensions and performance criteria were verified throughout the manufacturing process.
- Collaborated with external auditors during annual reviews, ensuring a seamless audit process with minimal findings or discrepancies noted.
- Championed validation efforts for new equipment installations or process changes by creating protocols, executing tests, analyzing data and generating reports demonstrating compliance with established criteria.
- Supported organizational growth initiatives by participating in new business proposals or customer presentations showcasing the company''s commitment to delivering high-quality products.
- Managed and supervised the site quality inspection team, ensuring adherence to regulatory requirements and customer specifications in the manufacturing of medical devices within cleanroom settings.
- Led initiatives to streamline inspection processes and improve efficiency, resulting in a 45% reduction in inspection documentation time through the implementation of revised procedures and documentation formats.
- Implemented process improvements that reduced quality inspection time by over 25%, enhancing productivity and throughput without compromising quality standards.
- Conducted root cause analysis and implemented corrective actions for quality issues identified during inspections, resulting in a 20% decrease in non-conformances and improved product quality.
- Collaborated with cross-functional teams to assess and mitigate risks associated with product changes or process modifications, ensuring compliance with regulatory requirements and maintaining product integrity.
- Developed and maintained quality metrics and performance indicators to monitor and track quality trends, facilitating data-driven decision-making and continuous improvement efforts.
- Participated in supplier quality management activities, including supplier audits and performance evaluations, to ensure the quality and reliability of raw materials and components used in manufacturing.
- Provided training and guidance to production personnel on quality requirements, inspection techniques, and best practices, fostering a culture of quality awareness and accountability throughout the organization.
- Acted as a liaison between the quality department and other functional areas, facilitating communication and collaboration to resolve quality issues and drive process improvements.
- Contributed to the development and implementation of risk management strategies, including FMEA (Failure Mode and Effects Analysis), to proactively identify and mitigate potential quality risks throughout the product lifecycle.
Education
Bachelor of Science - Mechanical Engineering
University of Massachusetts Dartmouth
Massachusetts 05.1998
Skills
- Process & Continuous Improvement
- Six Sigma & Lean Leader and Trainer
- ISO And EU MDR Standards
- Quality Management System
- Process Improvement
- Personnel Training & Development
- GMP Leader & Trainer
- Corrective and Preventative Actions
- Quality Internal & External Auditing
- Customer Relationship Management
- Quality Management Systems
- Root Cause Analysis
- Cross-functional Collaboration
- Auditing (External & Internal
- Problem solving
- Quality Documentation Management
Certification
- Certified by ASQ as a certified Quality Engineer
- ISO 13485, AITF 16949, Internal and External Auditor
- Six Sigma Green & LEAN Yellow Belt
Timeline
Senior Quality Engineer (Interim Quality Manager)
Integra Life Science
05.2021 - Current
Quality Assurance Manager
LeachGarner
05.2018 - 05.2021
Senior Quality Engineer
Interplex
05.2015 - 05.2018
Sustaining Quality Engineer
Bridgemedica
01.2005 - 05.2015
Bachelor of Science - Mechanical Engineering
University of Massachusetts Dartmouth
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