Senior Supplier Quality Engineer - NPD & GMP Quality Leader

FITS, LLC; Juncos (PR); Hybrid; USD 70,000 - 100,000; Full time

Job summary

FITS, LLC is seeking a Supplier Quality professional for our Manufacturing/Engineering area in a hybrid role. The candidate will support supplier qualification, audits, and CAPA processes across distributors and 3PLs, ensuring GMP and quality standards are met throughout the NPD lifecycle.

Ideal candidates have an engineering degree, 4+ years in medical devices, and experience with SAP/TrackWise. Willingness to travel to external manufacturers is required.

Qualifications

• Bachelor's degree in Engineering and 4+ years of relevant experience, or an advanced degree with 2+ years in medical devices.
• Experience with SAP and TrackWise is desirable.
• Knowledge of GMP and regulatory standards is preferred.

Responsibilities

• Support the Supplier and Distribution Quality organization in ASL, QA agreements, supplier performance, audits, and validation activities.
• Qualify suppliers per company standards and administer a Certified Supplier Program as needed.
• Monitor parts and materials from procurement through manufacturing, via the CAPA process.
• Develop supplier audit schedules and ensure GMP compliance and quality standards.
• Evaluate supplier performance and provide recommendations on operations.
• Provide Pre-Market Supplier Quality Engineering support for NPD in collaboration with other functions.

Skills

Engineering Degree

Communication Skills

GMP Knowledge

Problem Solving

Education

Bachelor's degree in Engineering

Tools

SAP

TrackWise

Job description

FITS, LLC is seeking a Supplier Quality professional for our Manufacturing/Engineering area in a hybrid role. The candidate will support supplier qualification, audits, and CAPA processes across distributors and 3PLs, ensuring GMP and quality standards are met throughout the NPD lifecycle.

Ideal candidates have an engineering degree, 4+ years in medical devices, and experience with SAP/TrackWise. Willingness to travel to external manufacturers is required.