Supplier Quality Auditors

Responsibilities:

• Develop and implement audit plans for suppliers.
• Conduct audits of supplier facilities, processes, and documentation
• Interview personnel, observe operations, and review records.
• Identify and assess any deficiencies in the supplier's quality management system.
• Work with suppliers to develop corrective action plans.
• Follow up to ensure that corrective actions have been implemented effectively.
• Prepare audit reports that document the findings and recommendations.
• Stay up-to-date on regulatory requirements for the medical device industry
• Maintain relationships with suppliers and work collaboratively to improve their quality management systems.

Requirements:

• Bachelor's degree in a related field, such as engineering, science, or business
• 3+ years of experience in quality assurance, preferably in the medical device industry
• Experience in conducting audits of suppliers.
• Strong understanding of medical device design and development regulations, medical device manufacturing best practices, quality management system standards, and FDA regulatory requirements
• Excellent written and verbal communication skills
• Ability to work independently and as part of a team.
• Certified Medical Device Auditor (CMDA) certification
• Experience with ISO 13485 and other quality management system standards
• Experience with FDA regulatory inspections