Supplier Quality Engineer - Medical Packaging & Compliance

Ensera Group; Town of Poland (NY); On-site; USD 70,000 - 90,000; Full time

Job summary

A healthcare packaging company based in New York is seeking a Supplier Quality Engineer responsible for ensuring compliance and continuous improvement of suppliers for medical devices and pharmaceutical packaging materials. The ideal candidate will evaluate suppliers through audits and risk assessments, maintain regulatory documentation, and collaborate with multiple departments to drive enhancements. Qualified candidates should have a Bachelor's degree and 3–7 years of experience in supplier quality or quality engineering, along with strong knowledge of ISO standards and FDA regulations. This is an exciting opportunity to make a significant impact in a leading healthcare environment.

Qualifications

• 3–7+ years of experience in supplier quality or quality engineering.
• Strong knowledge of FDA regulations and EU MDR.
• Experience with CAPA and root cause analysis.

Responsibilities

• Evaluate and qualify new suppliers for compliance.
• Conduct supplier audits to ensure regulatory compliance.
• Maintain the Approved Vendor List and supplier documentation.

Skills

ISO 13485 knowledge

Quality engineering

Supplier audits

Project management

Fluent in English

Education

Bachelor’s degree in Engineering, Quality, Life Sciences

Tools

FMEA

Risk management tools

Job description

A healthcare packaging company based in New York is seeking a Supplier Quality Engineer responsible for ensuring compliance and continuous improvement of suppliers for medical devices and pharmaceutical packaging materials. The ideal candidate will evaluate suppliers through audits and risk assessments, maintain regulatory documentation, and collaborate with multiple departments to drive enhancements. Qualified candidates should have a Bachelor's degree and 3–7 years of experience in supplier quality or quality engineering, along with strong knowledge of ISO standards and FDA regulations. This is an exciting opportunity to make a significant impact in a leading healthcare environment.