Associate QMS Manager

Join a high-impact quality team where you’ll drive the QMS activities that keep our Dallas site audit-ready, compliant, and performing at its best. In this role, you’ll champion continuous improvement, elevate regulatory maturity, and ensure our QMS processes not only meet—but exceed—regulatory, customer, and medical-device requirements. You’ll help prepare the site for regulatory and registrar audits, support certification readiness, and partner with functional leaders to strengthen processes that reduce COPQ, improve yield, and enhance overall product quality.

As the business process owner for CAPA and Internal Audits, you’ll lead critical quality initiatives while collaborating across manufacturing, engineering, logistics, sales, and Global Quality. This role is perfect for a quality systems professional who thrives on cross-functional teamwork, training others, managing projects, and making a measurable impact. If you’re ready to elevate quality performance and help ensure exceptional outcomes for our customers, this is your opportunity.

• Support site teams in continuous improvement and maturity, focusing on assigned Business Process Owner (BPO) areas.
• Provide coaching and mentoring to ensure success in execution and audit readiness.
• Write effective CAPA responses to regulatory findings and lead improvements in QMS infrastructure for ISO requirements.
• Facilitate training sessions for audit preparedness and ISO certification support.
• Manage and improve quality metrics, including inspection reduction, defect elimination, rework reduction, and yield improvements.
• Collaborate with cross-functional teams to develop capabilities, address challenges, and drive strategic initiatives.
• Communicate technical information clearly to senior management, customers, and teams, influencing decisions and aligning goals.
• Lead without direct reports, fostering collaboration, team building, and professional growth through mentorship.
• Manage multiple projects, ensuring timely and accurate delivery while meeting firm deadlines.
• Demonstrate business acumen with negotiating skills, the ability to handle difficult conversations, and fiscal responsibility in budget planning.
• Exhibit high energy, organization, and attention to detail, driving alignment with organizational objectives and industry best practices.
• Work autonomously, escalating issues as needed and balancing operational needs with financial constraints.
• Ability to travel occasionally (2-3 times per year) domestically and internationally.
• Other duties and responsibilities as assigned.

• A bachelors or higher degree or 6-8 years' experience in any combination of Quality Systems and regulatory affairs required.
• Familiarity in FDA Device Good Manufacturing Practices (GMP) is preferred.
• Expertise in ISO 13485, 9001, AS9100, and 14001 standards.
• Proven experience in leading projects, performing quality audits, and authoring procedures.
• Proficiency in quality data analysis tools and investigation methods.
• Preferred certifications: Six Sigma (Green/Black Belt), American Society of Quality (ASQ) CMQ/OE, CQA, RAPS, Project Management, or Lead Auditor.
• Experience in Medical, Aerospace/Defense, or Automotive industries required.
• Background in large or mid-sized electronics manufacturing preferred.

• Proficient in use of Lean and Six Sigma, or other process improvement methodologies and quality tools (i.e. Pareto Chart, Histogram, SPC, Flowchart, etc.).
• Proficient in use of PFMEA, Control Plans, Measurement System Analysis, APQP and PPAP.
• Proficiency in interpretation of assembly prints and drawings.
• Excellent English communications skills (verbal and written)
• Able to effectively present information to top management, public group and/or customers.