Supplier Quality Engineer II - NPD & GMP Focus

FITS, LLC; Villalba (PR); On-site; USD 60,000 - 80,000; Full time

Job summary

FITS, LLC is looking for an Engineer in the Manufacturing area located in Villalba, Puerto Rico. The ideal candidate should hold a Bachelor’s Degree in Engineering and have at least three years of experience in the Medical Devices Industry. Bilingual skills in Spanish and English are essential.

This role involves ensuring quality delivery from suppliers, qualifying suppliers, and providing compliance support throughout the product lifecycle. Strong problem-solving skills, communication abilities, and a collaborative mindset are crucial.

Qualifications

• 3 years of experience within the Medical Devices Industry.
• Experience in Process Validation and Computer Software.
• Shift availability according to business needs.

Responsibilities

• Ensure suppliers deliver quality parts, materials, and services.
• Qualify suppliers according to company standards.
• Develop and prioritize an auditing schedule for suppliers.
• Evaluate suppliers' internal functions and provide feedback.
• Provide Pre-Market Quality Engineering support in NPD.
• Provide technical guidance for Quality compliance.
• Collaborate with Component Engineers for product strategies.
• Define Receiving Inspection requirements and test validations.

Skills

Bilingual: Spanish and English

Writing and communication skills

Problem-Solving Techniques

Root Cause Analysis

Computer proficiency

Education

Bachelor’s Degree in Engineering

Job description

FITS, LLC is looking for an Engineer in the Manufacturing area located in Villalba, Puerto Rico. The ideal candidate should hold a Bachelor’s Degree in Engineering and have at least three years of experience in the Medical Devices Industry. Bilingual skills in Spanish and English are essential.

This role involves ensuring quality delivery from suppliers, qualifying suppliers, and providing compliance support throughout the product lifecycle. Strong problem-solving skills, communication abilities, and a collaborative mindset are crucial.