Quality & Regulatory Lead (Medical Devices)

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

Job summary

Amphenol CMT is seeking a Quality Assurance and Regulatory Affairs leader to oversee the site quality organization, regulatory plans, and QMS compliance across the campus. You will guide CAPA, change management, complaint investigations, and process validation for medical devices and flex circuits.

You will collaborate with internal teams, customers, and regulators to ensure product conformance, risk mitigation, and continuous improvement, while mentoring engineers and technicians towards

Qualifications

• Bachelor's degree in engineering or related field; required.
• 5+ years of management experience in multiple quality areas.
• Medical device regulatory experience with 3+ years.
• ISO 13485 Lead Auditor certified preferred.

Responsibilities

• Oversee quality management, regulatory affairs, metrology/inspection, and document control.
• Lead risk-based management for change control, investigations, CAPA, and business continuity.
• Coordinate regulatory plans with product transfers, legacy, and modifications.
• Address customer complaints and drive root-cause analysis and corrective actions.
• Maintain QMS effectiveness and coordinate audits and approvals.

Skills

MS Office

SharePoint

Judgement and decision making

Quality Control

Reading Comprehension

Active Listening

Education

Bachelor's degree in Engineering, Pharmaceutical, Chemical, Biological, Biomedical, or process related field

Tools

SAP

HRIS

Statistical software

Job description

Amphenol CMT is seeking a Quality Assurance and Regulatory Affairs leader to oversee the site quality organization, regulatory plans, and QMS compliance across the campus. You will guide CAPA, change management, complaint investigations, and process validation for medical devices and flex circuits.

You will collaborate with internal teams, customers, and regulators to ensure product conformance, risk mitigation, and continuous improvement, while mentoring engineers and technicians towards