Quality & Regulatory Manager, Medical Devices

Amphenol Cable and Interconnect Technologies Inc. in; Snoqualmie (WA); On-site; USD 115,000 - 150,000; Full time

Job summary

Amphenol Cable and Interconnect Technologies Inc. is seeking a Quality Manager (Finance) to oversee the quality organization, regulatory affairs, and the QMS across the manufacturing campus.

You will drive risk-based management, investigate complaints, lead CAPA, and coordinate regulatory plans to ensure compliance with global standards. The role requires strong leadership, data-driven decision making, and collaboration with manufacturing, engineering, and facility leadership to meet quality,

Qualifications

• Bachelor's degree in Engineering, Pharmaceutical, Chemical, Biological, Biomedical, or process related field; 5+ years management experience with progressive quality roles.
• Medical device regulatory experience with 3+ years' experience improving QMS.
• Ability to apply algebraic and statistical tools for analysis of product and process.

Responsibilities

• Lead quality management, regulatory affairs, metrology/inspection, document control, and regulatory affairs for the site.
• Manage risk-based change management, complaint investigations, nonconforming materials, CAPA and business continuity.
• Coordinate regulatory plans, audits, and inspections; ensure ISO QMS compliance; mentor quality engineers and technicians.

Skills

Quality management

Regulatory compliance

CAPA & investigations

Risk management

Data analysis

Education

Bachelor's degree in engineering/related field

Tools

ERP (SAP)

MS Office & SharePoint

Statistical software

Job description

Amphenol Cable and Interconnect Technologies Inc. is seeking a Quality Manager (Finance) to oversee the quality organization, regulatory affairs, and the QMS across the manufacturing campus.

You will drive risk-based management, investigate complaints, lead CAPA, and coordinate regulatory plans to ensure compliance with global standards. The role requires strong leadership, data-driven decision making, and collaboration with manufacturing, engineering, and facility leadership to meet quality,