Supplier Quality Engineer - Medical Devices (ISO 13485)

FITS, LLC; Juncos (PR); On-site; USD 85,000 - 125,000; Full time

Job summary

FITS, LLC provides supplier quality services in the Manufacturing and Engineering area, focusing on medical devices. You will ensure supplier quality and compliance across parts, materials, and services, while coordinating with R&D, sourcing, engineering, and operations to prevent defects and maintain high product quality.

The role involves evaluating suppliers, applying corrective actions, and supporting continuous improvement in accordance with industry standards and customer requirements.

Qualifications

• Bachelor's degree in Engineering with 4+ years of relevant experience, or advanced degree with 2+ years in medical devices.
• Shift is administrative and per business needs.
• Experience with Agile and Trackwise; knowledge of ISO 13485 requirements, FDA QMSR, and geometric tolerances.

Responsibilities

• Ensures suppliers deliver quality parts, materials, and services.
• Qualifies suppliers per company standards and may administer a Certified Supplier Program.
• Monitors parts from acquisition through manufacture and resolves supplier issues.
• Evaluates supplier internal functions and provides performance feedback.
• Collaborates with cross-functional teams to ensure quality and regulatory compliance.
• Provides guidance on quality compliance throughout the product lifecycle and supplier changes.
• Helps develop and deliver Product Acceptance Sampling Strategy and Approved Supplier List processes.
• Defines receiving inspection requirements and validation for internal test methods.

Skills

Communication skills

Teamwork

Maintenance skills

Quality mindset

Education

Bachelor's degree in Engineering

Advanced degree

Tools

Trackwise

ISO 13485 requirements

FDA QMSR

Geometric tolerances

Job description

FITS, LLC provides supplier quality services in the Manufacturing and Engineering area, focusing on medical devices. You will ensure supplier quality and compliance across parts, materials, and services, while coordinating with R&D, sourcing, engineering, and operations to prevent defects and maintain high product quality.

The role involves evaluating suppliers, applying corrective actions, and supporting continuous improvement in accordance with industry standards and customer requirements.