Director of Quality & Regulatory Affairs

COMPANY OVERVIEW: The company is a world leader in real-time supply chain tracking and sensing solutions. They design, produce, and support a complete line of wireless tracking and sensing devices, applications, and services. They have products deployed in over 180 countries, supporting hundreds of global customers. Our client is driven by our customer-centric, results-focused team, with a hunger to deliver high-quality products and a spirit of continuous innovation. POSITION OVERVIEW: Our client is seeking an experienced quality assurance and regulatory leader to own and manage the development, implementation, oversight, and ongoing operation of quality management systems and compliance programs to ensure products and services meet regulatory and quality standards. This role manages compliance initiatives, conducts audits, handles corrective actions, supports customers, and directs personnel to implement and improve operational processes related to quality, compliance, safety, and security. They are looking for someone local to the Dallas/Fort Worth area who is comfortable working full-time from their headquarters in Fort Worth. This role will involve working with internal teams, external contractors, regulatory bodies, suppliers, and customers to support all aspects of quality and compliance. Ultimately, you will ensure that products, services, and systems are properly architected and built to effectively secure, scale, and support their global customer base while complying with all relevant industry standards and regulations. You should have a demonstrated background in leading quality and compliance, ideally with experience in electronics manufacturing. You should possess a keen eye for detail, excellent communication skills, and a passion for ensuring quality. You should be an enthusiastic self-starter who is equally comfortable doing the work yourself or working as part of a team. You should not be intimidated by a rapid pace and managing multiple projects simultaneously, often involving international resources. You should have experience working with international teams and a willingness to lead and participate in meetings that may need to occur at odd hours to coordinate effectively with overseas resources. International travel will be required, so you should maintain a valid passport and be willing to travel anywhere the company is conducting business. Our client works as a close-knit, high-velocity team in a cross-functional environment that involves coordination with customers, suppliers, management, operations, and engineering departments. They can't promise it will be easy, but they can promise it will be interesting and fast-paced with many opportunities to innovate and grow your skillset and experience. RESPONSIBILITIES: Own and maintain the QMS in accordance with applicable ISO standards Serve as the primary point of contact for external and internal audits, including certification bodies and customer audits Ensure controlled documentation, revision control, change management, and record retention meet standards and regulatory requirements Lead management review processes, including KPI development, risk assessment, and performance reporting Interpret standards and regulations and translate requirements into operational procedures Communicate with and support our customers in all aspects of quality assurance and regulatory compliance processes, paperwork, and audits Establish and lead training programs for internal and external personnel Ensure products comply with all applicable local, regional, and international regulations (e.g., FCC, CE, IC, ANATEL, REACH, RoHS, ISO, UL, etc.) Ensure adequate documentation to support our customers with industry-specific regulatory compliance initiatives, including Aviation and Pharma (e.g., Airline approvals, 21 CRF Part 11, GDP/GxP, cGMP, etc.) Ensure our services, software systems, and contractual documents comply with international data security and privacy regulations (e.g., GDPR, ISO 27001, SOC 2, HIPAA) Monitor regulatory changes and assess impact on existing and new products Lead product certification, testing, documentation, and labeling requirements Maintain technical files, declarations of conformity, and compliance records Interface directly with registrars, regulatory bodies, and key customers Interface directly with internal engineering and operations teams to support regulatory activities Ensure compliance with electronic assembly workmanship and process standards. Qualify and audit contract manufacturing resources, including reviewing and approving manufacturing process documentation such as work instructions, inspection criteria, compliance logs, and control plans Partner with manufacturing, operations, engineering, and quality teams to maintain certification readiness, ensure design for manufacturability (DFM), and design for compliance (DFC) Manage the end-to-end RMA process, including authorization, receipt, inspection, repair/replacement, and disposition. Serve as the primary point of contact for RMA-related inquiries from customers, sales, service, and operations teams Review and approve RMA requests in accordance with warranty and return policies, and coordinate with engineering and operations to ensure timely processing of RMAs Track RMA metrics, including turnaround time, defect trends, root causes, and cost impact I dentify recurring product or process issues, work with engineering and operations teams on corrective and preventive actions, and prepare associated reports Present RMA and CAPA performance insights to management Manage inventory related to returns, repairs, and refurbishments. Manage scrap materials recycling and disposition as necessary Continuously improve RMA processes to increase efficiency and customer satisfaction Lead compliance-related projects from planning through execution, including certification initiatives, process improvements, and system implementations Manage timelines, resources, and cross-functional stakeholders to deliver projects successfully Apply continuous improvement methodologies to reduce defects and improve process capability Support validation activities related to process changes and new product introductions Manage supplier quality, including qualification, performance monitoring, and corrective actions Conduct and support supplier assessments and audits, including international suppliers Ensure global operations comply with applicable regulatory, customer, and certification requirements Travel internationally to support audits, supplier development, and compliance initiatives as needed PREFERRED PROFILE: Established background holding a long-term role in Engineering, Quality, Manufacturing, or other Quality/Compliance related roles, with 5+ years of experience in compliance, quality engineering, or QMS leadership, ideally within an electronics manufacturing environment Demonstrated expertise in ISO standards, audit execution, and regulatory compliance Strong technical understanding of electronic assembly processes and industry certification standards Proven experience leading RMAs, CAPAs, and structured problem-solving initiatives Project management experience in regulated or high-reliability manufacturing environments Ability and willingness to travel internationally, including leading and participating in meetings with suppliers in different time zones (periodic late-night and early-morning meetings will occur with overseas suppliers, regulatory bodies, and contract manufacturing resources). Patience and the ability to work through language barriers will be key QMS platforms and electronic document control systems Audit planning and execution Proficiency with software tools, including Microsoft Office Suite, Microsoft Teams, and JIRA Strong oral and written communication skills, attention to detail, and strong organizational skills Experience with statistical analysis methods, advanced root cause analysis techniques, and FMEAs is a plus Specific experience in aviation/aerospace, pharmaceutical, and cold chain sectors is a plus LOCATION: Dallas/Fort Worth, TX Job ID# 3545738 Artemis invites you to subscribe to our free Job Alerts and " The Hunt " Blog for free insights on hiring and career development. Artemis Referral Bonus - $1000! If you know someone for this job, please join our Referral Bonus Program .

Created: 2026-03-04