Conduct Supplier Audits: Evaluate quality management systems, processes, and documentation to ensure regulatory compliance, and track non-conformances and corrective actions.
Supplier Qualification and Assessment: Assess new suppliers for suitability and regularly reassess existing suppliers to ensure ongoing compliance and consistent performance.
Issue Resolution & Continuous Improvement: Collaborate closely with suppliers to implement and verify the effectiveness of CAPAs and drive continuous improvement initiatives.
Documentation & Reporting: Maintain complete audit documentation and prepare audit results and performance metrics for senior management.
Cross-functional Collaboration & Communication: Work closely with internal stakeholders and support suppliers in meeting quality and regulatory requirements.

Bachelor’s degree from an accredited college or university or equivalent industry experience
Fundamental experience in a quality-related auditing role in a regulated industry
Certified Lead Auditor from an accredited agency (AAMI, ASQ, ISO, etc.), ISO 13485 preferred
In-depth knowledge of industry standards and regulations (Ex: ISO 13485, ISO 9001, ISO 17025, ISO 22716, FDA, CFR, EU MDR)
Strong analytical, root-cause analysis, and problem-solving skills
Excellent English written and verbal communication skills
Ability to work independently and manage multiple projects simultaneously
Proficiency in Microsoft Office Suite and quality management software
Keen attention to detail, with the ability to identify small issues that could escalate into larger problems if left unaddressed
Must demonstrate a high level of integrity, professionalism, and adherence to ethical standards in their conduct
Critical thinking skills are essential, enabling the candidate to make sound judgments
Strong team player, capable of working effectively with others, and possess the adaptability to handle changing priorities and work environments.

Supplier Quality Auditor

Key skills