The compensation for this position will be between $170,000 - $190,000 annually with potential for 20% annual bonus. Actual compensation will be based on applicable experience and education/training.

Summary

The Director, Quality Engineering provides global leadership for the Quality Engineering function supporting product development, manufacturing, distribution, supplier quality, and post-market activities. The role develops and implements Quality Engineering strategies, standards, processes, and technical capabilities that ensure medical devices are designed, manufactured, and distributed in accordance with applicable safety, efficacy, quality, customer, and regulatory requirements.

The Director leads and develops a high-performing Quality Engineering organization supporting manufacturing facilities and distribution operations. The role embeds prevention-based Quality Engineering practices throughout the product lifecycle, from early product development and new-product introduction through commercial manufacturing, distribution, and post-market support.

The role partners with Research and Development, Operations, Engineering, Product Supply, Supplier Quality, Regulatory Affairs, and other functions to improve product and process robustness, reduce quality-related risks, and ensure Quality Engineering practices support business growth, operational performance, and customer expectations.

Responsibilities

• Develops and executes the global Quality Engineering strategy in alignment with the company’s Quality Assurance strategy, product-development priorities, manufacturing objectives, and business requirements.
• Leads the global Quality Engineering function and provides direction to Quality Engineering professionals, managers, and technical teams supporting manufacturing facilities and distribution operations.
• Establishes Quality Engineering standards, governance, processes, tools, and performance expectations across the product lifecycle.
• Provides technical Quality leadership supporting the development, manufacture, distribution, and post-market management of safe, effective, and compliant products.
• Embeds prevention-based Quality Engineering practices into early product development, new-product introduction, design transfer, manufacturing, distribution, and post-market activities.
• Partners with Research and Development, Operations, Engineering, Product Supply, Supplier Quality, Regulatory Affairs, and other functions to ensure Quality requirements are incorporated into business and technical decisions.
• Leads Quality Engineering activities associated with design controls, risk management, product and process development, process validation, inspection planning, statistical methods, and process capability.
• Develops and implements product-evaluation methods and Quality Engineering practices that ensure products and processes meet regulatory requirements, internal standards, and customer expectations.
• Directs Quality Engineering support for new-product introductions, design transfers, manufacturing transfers, process changes, product changes, and other significant technical initiatives.
• Analyzes Quality and operational data and establishes Quality Engineering programs that improve product quality, process robustness, manufacturing capability, and operational efficiency.
• Establishes data-driven monitoring systems and performance indicators that identify product and process risks, predict outcomes, and support timely corrective action.
• Leads the standardization, integration, and continuous improvement of Quality Engineering practices across manufacturing and distribution locations.
• Establishes and maintains effective failure-investigation and resolution practices for internal and external product-quality issues.
• Provides Quality Engineering leadership for root-cause investigations and ensures appropriate technical rigor is applied to corrective and preventive actions, nonconformances, complaints, and product-quality concerns.
• Supports corrective and preventive action activities and ensures investigations, corrective actions, closures, and effectiveness verifications are technically sound and appropriately documented.
• Provides Quality Engineering support for plant-based and distribution Quality activities, including process reliability, problem resolution, complaint investigations, document control, cost-of-quality improvement, and corrective and preventive actions.
• Drives a continuous improvement culture by using Quality data, cost-of-quality information, statistical methods, and engineering controls to improve manufacturing and distribution processes.
• Provides functional direction for Supplier Quality activities and partners with Product Supply to strengthen supplier selection, qualification, monitoring, development, and performance-management practices.
• Reviews Quality Engineering performance, identifies systemic risks and trends, and recommends appropriate improvement, remediation, or investment priorities.
• Provides senior leadership with timely updates regarding significant technical Quality risks, product and process performance, and recommended actions.
• Escalates significant product-quality, process, supplier, customer, and regulatory risks through the appropriate leadership and governance channels.
• Establishes priorities, allocates resources, and ensures Quality Engineering capabilities support the needs of the business.
• Builds, leads, coaches, and develops a high-performing Quality Engineering organization and establishes clear expectations and accountability for individual and team performance.
• Develops talent and succession plans that strengthen technical expertise, leadership capability, organizational continuity, and employee retention.
• Demonstrates excellent guest service to internal team members.
• Performs other related duties as assigned. 

 Qualifications

• Bachelor’s degree in engineering, science, statistics, quality, or a related technical discipline required; master’s degree preferred.
• 12+ years of progressive Quality Engineering, product-development Quality, or manufacturing Quality experience within a regulated medical device or similarly regulated environment.
• 5+ years of progressive people-leadership experience, including responsibility for leading Quality Engineering professionals, managers, or highly specialized technical teams.
• Experience providing Quality Engineering leadership across multiple manufacturing facilities, distribution operations, business units, or geographic locations.
• Demonstrated experience developing and implementing Quality Engineering strategies, standards, processes, and technical capabilities.
• Extensive experience with design controls, product and process risk management, process validation, inspection planning, statistical methods, and process capability.
• Demonstrated experience supporting product development, new-product introduction, design transfer, manufacturing transfer, process changes, and commercial manufacturing.
• Strong knowledge of applicable FDA and international medical device Quality requirements, including ISO 13485, ISO 14971, and other relevant standards.
• Demonstrated experience leading complex failure investigations, root-cause analysis, corrective and preventive actions, nonconformance management, and effectiveness verification.
• Experience using Quality data, statistical analysis, cost-of-quality information, and performance indicators to identify risks and improve product and process outcomes.
• Experience supporting Supplier Quality activities, including supplier selection, qualification, monitoring, development, and performance management.
• Demonstrated experience leading the standardization, integration, or transformation of Quality Engineering practices across multiple locations.
• Experience partnering with Research and Development, Operations, Engineering, Product Supply, Supplier Quality, Regulatory Affairs, and other cross-functional leaders.
• Demonstrated experience communicating significant technical Quality risks, performance trends, and recommendations to senior leadership.
• Certified Quality Engineer, Certified Manager of Quality/Organizational Excellence, Lean Six Sigma, or equivalent certification preferred.
• Strong leadership and technical expertise in Quality Engineering within a regulated medical device or manufacturing environment.
• Advanced knowledge of design controls, risk management, process validation, statistical methods, inspection planning, process capability, and manufacturing Quality systems.
• Strong understanding of the product lifecycle, including product development, new-product introduction, design transfer, commercial manufacturing, distribution, and post-market activities.
• Strong people-leadership, coaching, talent-development, and succession-planning capabilities.
• Demonstrated ability to lead managers, technical professionals, and geographically dispersed teams.
• Ability to work independently in a fast-paced, cross-functional environment.

Physical Demands

• Sedentary work. Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects. Repetitive motion. Substantial movements (motions) of the wrists, hands, and/or fingers. The worker must have close visual acuity to perform an activity such as: preparing and analyzing data and figures; transcribing; viewing a computer terminal; extensive reading. Ability to lift to 15 lbs. independently not to exceed 50 lbs. without help.

If you feel this opportunity could be the next step in your career, we encourage you to apply. This position will accept applications on an ongoing basis.