Quality Manager

Amphenol CMT is a leading innovator in the design and manufacturing of advanced medical devices that transform and elevate patient care. We specialize in engineering high-performance interconnects, flex circuits, molded components, precision bearings, and fully integrated solutions for surgical, interventional, monitoring, and other mission-critical applications.

Guided by a culture of innovation, collaboration, and lean principles, we deliver exceptional solutions and premium service that set new standards in the industry.

As part of the global Amphenol family—one of the world’s largest providers of high-technology interconnect, sensor, and antenna solutions—CMT is proud to contribute to products that enable the electronics revolution and improve lives worldwide.

Micro Connex, a CMT business unit, is a recognized leader in developing and fabricating specialized flex circuit technologies for high-density, demanding applications—further expanding our expertise and impact across critical industries.

Oversee and manage quality organization and regulatory affairs activities within the department, including quality engineering, compliance, metrology/inspection, document control, and regulatory affairs as well as complete oversight of the quality management system of the entire manufacturing campus. Implements and maintains overall quality department objectives and initiatives to meet corporate and customer requirements. Address complex project problems, incorporates risk management tools, and works with manufacturing managers, engineering managers, and facility leadership to develop data driven solutions to achieve productivity, quality, customer satisfaction goals and objectives.

• All Quality Management Representative responsibilities, commitment, and planning established in applicable global regulations.
• Maintains high understanding of requirements from customers and regulators.
• Leads site in application of risk-based management especially as it pertains to change management, complaint investigations, nonconforming materials, CAPA and maintaining business continuity.
• Develop and coordinate regulatory plans with full implementation of new, transfer, legacy, and modified products.
• Provides exceptional, professional service resolving customer complaints, troubleshooting of quality issues with diverse teams, lead causal analysis activities to drive to root cause and corrective action.
• Ensures timely feedback from Voice of Customer, audits and KPIs for effective management review and function as the facility ISO Management Representative.
• Surveillance of the compliance and effectivity of the Quality Management System while using risk-based approaches to improve the QMS performance.
• Coordinate regulatory research to support validation and verification submissions and regulatory advice.
• Establishes Product Quality documentation and facilitates Quality System procedures, policies, training, implementation, and change management.
• Supports regulatory, registrar, and customer audits of our systems based on standards requirements.
• Coordinate with internal / external quality assurance auditors to ensure legal and regulatory compliance.
• Select and mentor quality engineers, and technicians, with development plans, growth opportunities and specific performance goals.
• Establishes objectives, communications, delegations, goals, tracking mechanisms (KPI), routine feedback and accountability
• Engage with facility leadership, continuous Improvement staff and internal teams to increase customer satisfaction by improving the capabilities of processes and product quality.
• Prepares product and process quality reports by collecting, analyzing, and summarizing information and trends.
• Ensure maintenance…