Miles MacDonald

Easton, PA ***** • 617-***-****

ad1lrx@r.postjobfree.com • LinkedIn

Director of Quality & Continuous Improvement

Results-driven and highly accomplished professional with extensive experience in continuous improvement and quality assurance management complemented by Lean Six Sigma Black Belt expertise and a robust background in ISO 9001 compliance.

Innate ability to implement robust quality systems, lead cross-functional teams, enhance operational efficiency, and elevate product/service quality. Dedicated to leveraging strategic planning, process optimization, and leadership to foster a culture of continuous improvement and deliver tangible business impact. Adept at executing quality management strategies aligned with organizational objectives and regulatory requirements to improve overall product quality. Instrumental in spearheading initiatives to streamline workflows and optimize processes while contributing to increased operational efficiency and maintaining the highest standards of quality/compliance. Capable of implementing data analytics tools to identify trends and root causes of quality issues aimed at facilitating proactive decision-making and reducing the occurrence of defects. Known for cultivating a culture of continuous improvement by championing Lean and Six Sigma methodologies. Astute at instituting cost-effective quality management programs to slash operational costs and maintain/enhance product and service quality standards. Articulate and refined communicator with exceptional interpersonal, leadership, analytical, relationship-building, problem-solving, and decision-making skills.

Areas of Expertise

Quality Management Continuous Improvement Lean Six Sigma Black Belt ISO 9001 Compliance Global Project Leadership

Cross-Functional Collaboration Process Optimization Risk Mitigation Change Management Project Management

Business Process Standardization Internal & External Audits Root Cause Analysis Quality Assurance & Control

Customer Relationship Building Team Leadership Operational Excellence Strategic Planning & Execution

Professional Experience

Air Products and Chemicals Inc. – Allentown, PA

Global Quality Assurance Design & Compliance Manager, GEMTE Quality & CI 2022 to Present

Utilize leadership skills to steer a team of 6 direct reports with a keen focus on managing change and overseeing the design and optimization of GEMTE's global quality management system. Direct process design and effectiveness efforts, aligning with global high-performance organizational measures and objectives. Conduct root cause analysis of process nonconformances and identify optimal ownership for corrective action.

Ensure ISO 9001:2015 multi-site certificate compliance across 8 regional operating centers spanning the Americas, Asia, Europe, and India aimed at supporting a diverse global project portfolio exceeding more than $30B in capital deployment.

Enhanced the design of the Electronic Database Management System (EDMS), resulting in heightened efficiency in servicing GEMTE's 3,400 organizational work processes and technical requirements.

Formulated and managed a robust ISO 9001:2015 internal audit program while integrating the GEMTE Organizational Risk Register to identify, monitor, and mitigate organizational risks.

Provided leadership to a team of 43 global functional process owners with special emphasis on fostering the development of standardized end-to-end business processes/KPIs, which ultimately drove process effectiveness, efficiency, and compliance.

Revitalized the quality onboarding process and crafted targeted, role-specific training programs. Instilled a quality and continuous improvement culture in response to the unprecedented organizational growth.

Americas Quality Assurance Manager, GEMTE Quality & CI 2021 to 2022

Orchestrated quarterly quality management reviews with senior leadership, ensuring the ongoing effectiveness of the management system. Oversaw the customer feedback and nonconformance database for the Americas, while assigning and prioritizing issues. Implemented root cause analysis and employed effective corrective actions. Provided vital support for business quality-related inquiries, including conducting QMS induction training for onboarding leadership and business process owners.

Led regional and global internal ISO 9001 audits to ensure risk mitigation, process effectiveness, and compliance.

Supported project quality assurance through the strategic development of project-specific quality plans, contributing to the overall success of project initiatives.

Played a pivotal role in supporting external ISO 9001 audits and preparing internal auditees for external assessment interviews.

Business Improvement Manager, GEMTE Quality & CI 2019 to 2021

Globally deployed to various GEMTE organizational units, focused on identifying and spearheading high-value Lean Six Sigma (LSS) projects and programs. Elevated KPI development and visibility across GEMTE aimed at streamlining the identification and prioritization of improvement opportunities. Facilitated numerous RCA, value engineering, and improvement workshops, representing diverse cross-functional business units like global engineering, capital procurement, technology, product line, quality, and operational excellence. Acted as interim GEMTE EH&S Safety Chair for the COO, providing critical coverage during an unplanned vacancy.

Acknowledged with multiple business awards for consistently exemplifying Air Products' core leadership values.

Led high-impact LSS improvement programs to optimize and standardize global estimating, global resource planning, and quality & enabling business processes. Delivered remarkable results, including $2M in hard savings and $10M in cost avoidance.

Conducted internal Lean Six Sigma Black Belt and Green Belt training, while coaching and mentoring several belts to successful project completion and certification.

Developed a comprehensive root cause failure analysis training program, standardizing the approach to ensure the effectiveness of analysis.

Led High-Performance Organization (HPO) tool effectiveness gap analysis workshops to identify/eliminate gaps in enterprise-wide systems and ensure end-to-end process performance and visibility.

W.R. Grace & Co. – Columbia, MD

Business Quality Manager, Grace Refining Technologies 2017 to 2019

Directed quality systems across manufacturing sites and spearheaded global standardization of quality processes. Trained site quality managers, facilitated quality coordination between corporate and manufacturing sites, and fostered customer relationship building. Monitored and trended quality metrics, ensured compliance with ISO 9001 standards, and executed business quality reviews in association with the global operational excellence organization. Managed project initiatives, provided site support, and ensured seamless execution.

Initiated a global standardization project to ensure product fungibility of quality documentation and manufacturing process control strategies, resulting in guaranteeing a consistent global customer experience.

Promoted to lead quality for Fluid Catalytic Cracking catalysts, managing 7 manufacturing facilities in Asia, Europe, and North America.

Successfully led the migration from ISO 9001:2008 to ISO 9001:2015 across North American operations, ensuring compliance with the latest quality management standards.

Appointed to both the Critical to Quality Control Plan and Advanced Process Control Implementation committees, contributing to the integration of business quality objectives into key strategic initiatives.

Quality Engineer, Grace Catalysts Technologies 2016 to 2017

Chaired monthly business quality reviews with top management and identified opportunities for specific customer requirement improvement initiatives to enhance overall operational efficiency.

Played a pivotal role in facilitating the seamless consolidation of new business acquisitions into Grace's quality organization, ensuring a smooth integration process.

Conducted comprehensive quality assessments for new acquisitions, evaluating three new manufacturing locations and overseeing the integration of 200+ additional employees into Grace's ISO 9001 registration certificate.

Lean Six Sigma Black Belt, Grace Catalysts Technologies 2014 to 2016

Led a cross-functional global team of R&D, product management, and operational excellence professionals to reevaluate raw material specifications based on critical product quality and performance requirements as compared to historical specifications. Identified and enforced viable opportunity projects, concurrently mitigating risks to quality and performance. Ensured successful project implementation in close collaboration with suppliers, toll manufacturers, cross-functional teams, and senior management.

Formulated a robust productivity opportunity pipeline valued at $15M, focusing on raw material standardization, optimization, and volume-leveraged strategic supply projects.

Mobilized cross-functional teams, integrating process owners from various departments such as R&D, sales, marketing, operations, quality, productivity, and environment, health, and safety (EHS).

Verified opportunities, minimized risks, and drove rapid implementation, resulting in the realization of projects with more than $10M in annualized cost reduction savings.

Additional Experience: W.R. Grace & Co., Cambridge, MA, Quality & Supply Chain Leader, Quality Assurance Manager, Lean Six Sigma Black Belt, Grace Construction Products Multiple Roles at Dupont Canada Inc., Maitland, ON, Canada

Education & Credentials

Bachelor of Science in Biology/Biochemistry Carleton University, Ottawa, ON, Canada

Certifications & Training

Six Sigma Black Belt Certification Lean Six Sigma Certification Process Operator: Refinery, Chemical, and Liquid Processes

Grace Construction Products Concrete School Certification Project Management: The Project Success Method

Covey: Seven Habits of Highly Effective People Covey: The Four Roles of Leadership Achieving Results Through Execution

Creating Effective Presentations Disciplined Process Improvement ISO 9001: 2015 Lead Auditor Root Cause Failure Analysis

Breaking the Bottleneck Effective Management Crucial Conversations Train the Trainer

Contact this candidate