Quality Management Leader: QMS, Regulatory & CAPA

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

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) with company match

Paid holidays & PTO

Job summary

Amphenol CMT seeks an experienced leader to oversee quality organization and regulatory affairs across the campus. You will ensure the Quality Management System remains compliant and effective, directing risk-based activities and data-driven improvements.

You will coordinate regulatory plans for new and legacy products, lead CAPA programs, and mentor a team of quality engineers to achieve customer satisfaction goals while maintaining manufacturing quality.

Qualifications

• Bachelor’s degree in Engineering, Pharmaceutical, Chemical, Biological, Biomedical, or process related field.
• 5+ years of management experience in multiple Quality Areas.
• Medical Device and Regulatory Experience with 3+ years improving QMS.
• Ability to apply algebraic and statistical tools to analyze product/process.

Responsibilities

• Oversee and manage the quality organization and regulatory affairs for the campus.
• Maintain and improve the Quality Management System to meet regulatory and customer needs.
• Lead risk-based management for change control, CAPA, complaints, and business continuity.
• Coordinate regulatory plans for new, transfer, legacy, and modified products.
• Resolve customer quality issues and drive root cause and corrective actions.
• Ensure audits, KPIs, and management reviews drive QMS performance.
• Mentor quality engineers and technicians with development plans and goals.
• Prepare quality reports and maintain product/process quality documentation.

Skills

Quality Management

Regulatory Affairs

Risk Management

Leadership

Data driven decision making

Education

Bachelor’s degree in Engineering, Pharma, Chemical, Biological, Biomedical, or related field

Tools

SAP

SharePoint

MS Office Suite

ERP

HRIS

Statistical software

Job description

Amphenol CMT seeks an experienced leader to oversee quality organization and regulatory affairs across the campus. You will ensure the Quality Management System remains compliant and effective, directing risk-based activities and data-driven improvements.

You will coordinate regulatory plans for new and legacy products, lead CAPA programs, and mentor a team of quality engineers to achieve customer satisfaction goals while maintaining manufacturing quality.