Senior QMS Lead — Medical Device Compliance

Regulatory Jobs; Newberg (OR); On-site; USD 90,000 - 120,000; Full time

Job summary

A-dec is seeking a Senior Quality Assurance Specialist to coordinate A-dec's QMS, ensuring audit readiness and compliance with US FDA, EU MDR, and ISO 13485 standards. You will lead internal audits, coordinate third-party inspections, and drive CAPA and improvement initiatives across a multi-site operation.

The role requires strong technical writing, cross-functional collaboration, and the ability to mentor junior QA staff. Some travel is expected for audits.

Qualifications

• Bachelor’s degree in science, engineering, or related field.
• Minimum four years in a QMS administrator role with knowledge of FDA, CMDR, EU MDR, ISO 13485, MDSAP.
• Experience as lead internal auditor preferred.

Responsibilities

• Lead internal audits for a multi-site operation and coordinate audit teams.
• Analyze audit results and drive CAPA and process improvements.
• Facilitate third-party audits and inspections as needed.
• Support Management Representative with key QMS processes.
• Oversee weekly customer complaints review and CAPA boards.

Skills

QMS administration

Internal auditing

CAPA management

Regulatory knowledge

FDA regulations

ISO 13485

Project management

Technical writing

Cross-functional leadership

Data analysis

eQMS software

MS Office

Education

Bachelor’s degree in science/engineering

4+ years QMS admin experience

Lead internal auditor experience

Tools

eQMS software

MS Office

Job description

A-dec is seeking a Senior Quality Assurance Specialist to coordinate A-dec's QMS, ensuring audit readiness and compliance with US FDA, EU MDR, and ISO 13485 standards. You will lead internal audits, coordinate third-party inspections, and drive CAPA and improvement initiatives across a multi-site operation.

The role requires strong technical writing, cross-functional collaboration, and the ability to mentor junior QA staff. Some travel is expected for audits.