Senior QMS Auditor - Medical Devices Compliance Lead

Regulatory Toolkit; Newberg (OR); Presencial; USD 90.000 - 130.000; Jornada completa

Descripción de la vacante

A-dec is seeking a Senior Quality Assurance Specialist to coordinate and maintain its QMS, ensuring audit readiness and compliance with US FDA, Health Canada, and EU MDR standards. The role leads internal audits, CAPA programs, and cross-functional collaboration to sustain quality across a multi-site operation.

You will coach QA staff, deliver training on quality topics, and support continuous improvement initiatives aligned with regulatory requirements and company values.

Formación

• Bachelor's degree in business, science or engineering, or equivalent experience.
• At least four years in a QMS administrator role with regulatory knowledge (FDA, ISO 13485, EU MDR).
• Experience as lead internal auditor of QMS preferred.

Responsabilidades

• Lead internal audits and coordinate audit teams across sites.
• Analyze audit results and drive corrective actions.
• Organize 3rd party audits and inspections.
• Support Management Representative with QMS processes.
• Facilitate weekly customer complaints review and CAPA boards.
• Mentor QA Specialists and deliver training.
• Maintain audit readiness and compliance with medical device regs.
• Travel up to 5 business days per year.

Conocimientos

QMS expertise

Internal audits

Regulatory compliance

Process improvement

Documentation

Project management

Cross-functional leadership

Data analysis

Training & mentoring

ISO 13485 knowledge

Educación

Bachelor's degree in business/science/engineering

Herramientas

eQMS software

MS Office

Descripción del empleo

A-dec is seeking a Senior Quality Assurance Specialist to coordinate and maintain its QMS, ensuring audit readiness and compliance with US FDA, Health Canada, and EU MDR standards. The role leads internal audits, CAPA programs, and cross-functional collaboration to sustain quality across a multi-site operation.

You will coach QA staff, deliver training on quality topics, and support continuous improvement initiatives aligned with regulatory requirements and company values.