Quality Systems & Compliance Leader (ISO 13485/MDR)

FLIR Systems, Inc.; California, Northern (MO, KY); Hybrid; USD 97,000 - 129,000; Full time

Job summary

Teledyne Technologies Incorporated seeks a Quality Systems and Compliance Manager to lead the QMS, ensure ISO 9001/13485 and MDR compliance, and oversee regulatory and supplier quality activities across the organization.

Responsibilities include internal audits, CAPA, post‑market surveillance, risk management, and continuous improvement, with cross‑functional leadership to uphold customer, regulatory, and company standards.

Qualifications

• Bachelor's degree in Engineering, Quality, Regulatory Affairs, Life Sciences, Manufacturing, or related discipline.
• Minimum 5–10 years of progressively responsible experience in quality management within a regulated manufacturing environment.
• ISO 13485 lead auditor or internal auditor certification preferred.
• ASQ CMQ/OE, CQE, or equivalent certification preferred.
• Experience supporting Notified Body, FDA, customer, and certification audits.
• Experience with MDR technical documentation and post-market surveillance.

Responsibilities

• Lead and maintain the organization's QMS in compliance with ISO 9001, ISO 13485 and MDR requirements.
• Support regulatory inspections, notified body audits, customer audits, and certification audits.
• Lead risk management activities in line with ISO 14971.
• Oversee supplier quality programs and supplier audits.
• Coordinate internal audits and management review data for leadership.
• Promote a culture of quality and continuous improvement.

Skills

QMS leadership

Regulatory compliance

Risk management

Auditing

Supplier quality

CAPA

Leadership

Continuous improvement

Education

Bachelor's degree in Engineering/Quality/Regulatory Affairs/Life Sciences/Manufacturing

Tools

MS Office

Dynamics AX/CRM

Power BI

Job description

Teledyne Technologies Incorporated seeks a Quality Systems and Compliance Manager to lead the QMS, ensure ISO 9001/13485 and MDR compliance, and oversee regulatory and supplier quality activities across the organization.

Responsibilities include internal audits, CAPA, post‑market surveillance, risk management, and continuous improvement, with cross‑functional leadership to uphold customer, regulatory, and company standards.