Quality & Regulatory Leader – Medical Devices

Amphenol CMT; Snoqualmie (WA); On-site; USD 115,000 - 150,000; Full time

Job summary

Amphenol CMT seeks a senior Quality and Regulatory Affairs leader to oversee the quality organization and regulatory activities across the manufacturing campus. You will manage quality engineering, compliance, metrology, document control, and the Quality Management System, driving data-driven improvements to productivity, quality, and regulatory readiness.

Responsibilities include leading risk-based changes, CAPA, customer audits, and coordinating regulatory plans for new and legacy products;

Qualifications

• Bachelor’s degree in Engineering or related field is required.
• 5+ years of management experience in multiple quality areas.
• Medical device and regulatory experience with 3+ years improving QMS.
• Ability to analyze data using mathematical and statistical tools.

Responsibilities

• Lead quality management representative responsibilities and planning.
• Maintain understanding of customer and regulatory requirements.
• Drive risk-based change management, CAPA, and supplier quality.
• Develop regulatory plans for new, transferred, legacy, and modified products.
• Coordinate audits and drive corrective actions with cross-functional teams.

Skills

Quality Management

Statistical analysis

MS Office

ERP (SAP)

Communication

Education

Bachelor’s degree in Engineering or related field

Tools

SAP

HRIS

Statistical software

Job description

Amphenol CMT seeks a senior Quality and Regulatory Affairs leader to oversee the quality organization and regulatory activities across the manufacturing campus. You will manage quality engineering, compliance, metrology, document control, and the Quality Management System, driving data-driven improvements to productivity, quality, and regulatory readiness.

Responsibilities include leading risk-based changes, CAPA, customer audits, and coordinating regulatory plans for new and legacy products;