Quality Systems & Regulatory Leader (ISO 13485/MDR)

Teledyne LeCroy Korea; California (MO); On-site; USD 97,000 - 129,000; Full time

Job summary

Teledyne Technologies Incorporated seeks a Quality Systems and Compliance Manager to develop, implement, and continually improve the QMS in line with ISO 9001:2015, ISO 13485:2016, and MDR requirements. You will lead quality assurance, regulatory compliance, risk management, supplier quality, audits, CAPA, and post-market surveillance across cross-functional teams.

The role requires strategic thinking, independent judgment, and strong leadership to ensure products and processes meet customer and

Qualifications

• Bachelor’s degree in Engineering, Quality, Regulatory Affairs, Life Sciences, or related discipline.
• 5–10 years of progressively responsible experience in quality management within a regulated manufacturing environment.
• ISO 13485 lead auditor or internal auditor certification preferred.
• Experience supporting Notified Body, FDA, customer, and certification audits.
• Strong leadership, communication, and organizational skills.

Responsibilities

• Establish and maintain the Quality Management System in compliance with ISO 9001, ISO 13485, and MDR requirements.
• Lead internal audits and report to executive management.
• Promote risk-based thinking and implement CAPA across the organization.
• Oversee product and process quality, supplier quality management, and post-market activities.
• Support regulatory inspections, submissions, and technical documentation.
• Mentor quality personnel and foster a culture of continuous improvement.

Skills

Quality Management System

ISO 9001:2015

ISO 13485:2016

EU MDR 2017/745

Regulatory compliance

Risk management

Internal audits

CAPA

Supplier quality management

Post-market surveillance

Education

Bachelor’s degree in Engineering, Quality, Regulatory Affairs, Life Sciences, or related discipline

Tools

MS Office

Dynamics AX/CRM

Power Bi

Job description

Teledyne Technologies Incorporated seeks a Quality Systems and Compliance Manager to develop, implement, and continually improve the QMS in line with ISO 9001:2015, ISO 13485:2016, and MDR requirements. You will lead quality assurance, regulatory compliance, risk management, supplier quality, audits, CAPA, and post-market surveillance across cross-functional teams.

The role requires strategic thinking, independent judgment, and strong leadership to ensure products and processes meet customer and