Senior Supplier Quality Engineer, Hybrid – GMP & NPD

FITS LLC; Juncos (PR); Hybrid; USD 70,000 - 90,000; Full time

Job summary

FITS LLC in Puerto Rico is seeking a Supplier Quality Engineer to support quality systems for medical devices suppliers and 3PLs. The role emphasizes establishing the Approved Supplier List (ASL), negotiating quality agreements, monitoring supplier performance, and audit scheduling to ensure GMP compliance.

You will collaborate with NPD, Component Engineering, and Distribution teams to prevent defects and ensure reliable parts, while providing CAPA-driven problem resolution.

Qualifications

• Bachelor's degree in Engineering and a minimum of four years of relevant experience in the medical devices industry.
• Bilingual English & Spanish communication abilities.
• Work Type: Hybrid.
• Experience in Distribution Centers and 3PL suppliers.
• Experience in leading projects.
• SAP, Agile and Trackwise desired.

Responsibilities

• Support the Supplier and Distribution Quality organization by establishing the Approved Supplier List (ASL) for Distributors and 3PLs, negotiating Quality Agreements, monitoring supplier performance, and supporting supplier validation and qualification activities.
• Qualify suppliers according to company standards and administer a Certified Supplier Program within Receiving Inspection.
• Monitor parts, materials, and services from acquisition through manufacturing, and resolve supplier-related issues via CAPA.
• Develop and prioritize supplier audit schedules to ensure GMP compliance and adherence to quality standards.
• Evaluate supplier performance and provide feedback and recommendations.
• Provide Pre-Market Supplier Quality Engineering support for New Product Development (NPD) in collaboration with Component Engineering and Distribution teams.
• Collaborate with Distribution in selecting new Distributors and 3PLs.
• Define Receiving Inspection requirements and test method validation as needed.
• Provide technical guidance and ensure quality compliance across the NPD lifecycle for newly qualified parts.
• Implement strategies to drive product quality and continuous improvement, ensuring purchased products are manufactured and qualified per standards.
• Collaborate with Component Engineers to develop and deliver Product Acceptance Sampling Strategy and related plans.
• Availability to travel to external Contract Manufacturers and Suppliers.

Skills

Bilingual English & Spanish

Education

Bachelor's degree in Engineering

Tools

SAP

Agile

Trackwise

Job description

FITS LLC in Puerto Rico is seeking a Supplier Quality Engineer to support quality systems for medical devices suppliers and 3PLs. The role emphasizes establishing the Approved Supplier List (ASL), negotiating quality agreements, monitoring supplier performance, and audit scheduling to ensure GMP compliance.

You will collaborate with NPD, Component Engineering, and Distribution teams to prevent defects and ensure reliable parts, while providing CAPA-driven problem resolution.