Supplier Quality Engineer

📋 Description

• Conduct assigned Supplier Audits as Lead Auditor per Global Supplier Audit Schedule, including
• Execute Audit Reports with necessary Audit Response Forms and Supplier Responses.
• Own Supplier Quality processes including Supplier Controls, Global Supplier Manual, Supplier
• Run quarterly Supplier Monitoring Boards with cross-functional stakeholders, presenting Supplier
• Periodically analyze and review Supplier Controls processes in partnership with Regulatory
• Lead internal CAPAs related to Supplier Controls.

🎯 Requirements

• Minimum 3 years of related experience in Supplier Quality and/or Supplier Development or a related
• Excellent knowledge of 21 CFR Part 820, ISO 13485:2016, EU MDR, and MDSAP regulations, with
• ISO 13485 Lead Auditor Certification.
• Ability to work with highly technical teams and communicate effectively in an engineering-driven
• Strong organizational, written, and verbal communication skills with proven ability to prioritize
• Excellent presentation skills, including executive-level management presentations.