Supplier Quality Engineer - Medical Devices (Audits & CAPA)

vVARDIS; United States; On-site; USD 110,000 - 160,000; Full time

Job summary

vVARDIS is seeking a Supplier Quality Engineer to own the quality of externally sourced materials, components, and services. You will qualify new suppliers, audit them, and track performance to ensure all inputs meet patient safety standards.

You will partner with Quality, Operations, R&D, and Regulatory Affairs, leading risk-based supplier management and driving improvements. Travel for on-site audits will be required; role reports to Senior Manager, Quality Engineering & Operations.

Qualifications

• 3–5 years of hands-on supplier quality experience in medical devices.
• Bachelor's or Master's degree in Engineering, Life Sciences, or related field.
• Experience with ISO 13485, EU MDR, and FDA 21 CFR 820 in supplier mgmt.

Responsibilities

• Lead qualification of new suppliers and contract manufacturers.
• Plan, prepare, and run supplier audits on-site and remote.
• Maintain the Approved Supplier List (ASL) in the QMS.
• Define and track supplier KPIs and CAPA effectiveness.
• Manage supplier-related nonconformances and deviations.
• Develop and maintain Quality Agreements with suppliers.

Skills

Supplier quality

Auditing

ISO 13485

CAPA management

Education

Bachelor's or Master's in Engineering/Life Sciences

Tools

eQMS platforms

Microsoft Office

Job description

vVARDIS is seeking a Supplier Quality Engineer to own the quality of externally sourced materials, components, and services. You will qualify new suppliers, audit them, and track performance to ensure all inputs meet patient safety standards.

You will partner with Quality, Operations, R&D, and Regulatory Affairs, leading risk-based supplier management and driving improvements. Travel for on-site audits will be required; role reports to Senior Manager, Quality Engineering & Operations.