Senior Quality Manager - TEQ

TEQ, a division of Toppan, is a leader in thermoformed medical device packaging and medical devices. We are seeking a high-impact Senior Quality Manager to lead our quality operations across two manufacturing sites in Huntley, IL. This role serves as the quality subject matter expert (SME) and will play a critical leadership role in driving quality strategy, regulatory compliance, and operational consistency. Growth opportunity includes expansion of responsibilities across additional sites in the Chicago area and Tijuana, Mexico.

What you’ll be doing:

• Lead and mentor a quality team of 20+, including quality engineers, technicians, and document control personnel.
• Define and implement quality strategy aligned with medical device and healthcare packaging standards.
• Standardize quality systems and processes across multiple manufacturing sites.
• Foster a culture of quality excellence, regulatory compliance, and continuous improvement.
• Ensure compliance with ISO 13485 and ISO 9001 Quality Management Systems (QMS).
• Oversee internal, customer, and regulatory audits (FDA, notified bodies).
• Manage CAPA, FMEA, validation protocols, and change control processes.
• Lead Management Review processes and drive data-based decisions using ASQ methodologies.
• Act as the primary quality liaison to key customers and suppliers.
• Negotiate and manage Quality Agreements to support business growth.
• Collaborate cross-functionally (Engineering, Operations, Sales, Regulatory) to align quality with customer expectations.
• Develop quality team talent pipeline and succession plans.
• Support integration of new sites and scale quality practices for geographic expansion.

This position is located at our Huntley, IL Facility and 100% onsite

We’d love to hear from you if:

• Bachelor’s degree in engineering, quality, or related technical discipline.
• 5+ years of quality leadership experience in medical devices, pharma, or highly regulated manufacturing.
• Deep understanding of ISO 13485, ISO 9001, and FDA QSR compliance.
• Hands-on experience with CAPA, FMEA, validation, and change control systems.
• Proven success leading multi-site quality systems and audits.
• Strong leadership presence with the ability to influence across functions and geographies.
• Excellent communication and negotiation skills, particularly in customer-facing settings.
• Strategic thinker with a passion for continuous improvement and problem-solving.
• High degree of accountability and follow-through in complex operational environments.