Staff Supplier Quality Engineer - ISO 13485 Lead Auditor - Remote from USA (50% Travel Internationally)

Role overview

Lead supplier quality work for medical device manufacturing, helping ensure external suppliers and their processes meet quality system and regulatory expectations. The role combines supplier audits, quality engineering, and cross-border collaboration, with a remote U.S. work arrangement and substantial international travel.

Responsibilities - Lead supplier audits against ISO 13485 and assess supplier quality systems and practices. - Evaluate supplier processes and quality performance to support compliance and reliable production. - Work with suppliers and internal partners to address quality issues and improve processes. - Travel internationally for supplier visits and audit work, at an expected level of about 50%.

Requirements - Lead auditor capability and experience applying ISO 13485 in a medical device quality context. - Supplier quality engineering experience, including assessing external suppliers. - Ability to work across organizational and geographic boundaries to resolve quality matters. - Availability to work remotely from the United States and undertake frequent international travel.