Quality Engineer II

Medial Group; Puerto Rico; On-site; USD 65,000 - 90,000; Full time

Job summary

Medial Group is seeking a diligent Quality Engineer II to embed quality into process improvements within our medical device manufacturing operations. You will act as the quality guarantor, ensuring faster processes remain safe, compliant, and high quality.

The role requires 2+ years in a regulated manufacturing environment, experience with lean transformations, validation, and cost analysis, and strong English/Spanish communication. On-site in Villalba, PR.

Qualifications

• Minimum 2+ years in a quality or engineering role within a regulated manufacturing environment.
• Experience with lean manufacturing concepts and transformations.
• Equipment and process validation experience.
• Cost analysis experience.
• Strong analytical problem solving and communication skills (English & Spanish).

Responsibilities

• Quality Integration into process improvement projects.
• Validation & Verification (processes and equipment).
• Risk Management and Mitigation.
• Data Analysis and Metrics Tracking.
• Lean Manufacturing Concepts Implementation.
• Documentation Development, Procedures, and Training.
• Regulatory Compliance & Auditing.
• Cross-Functional Team Collaboration.
• Project Planning and Management.

Skills

Quality

Engineering

Lean

Regulated Manufacturing

Data Analysis

Communication

Bilingual (English/Spanish)

Education

Bachelor's Degree in Industrial Engineering

Job description

Villalba, Puerto Rico | Posted on 08/26/2025

We are seeking a diligent and proactive Quality Engineer II to join our Flow Acceleration / Lean Transformation team. The primary responsibility of this role is to embed quality principles into all process improvement and flow enhancement initiatives within our medical device manufacturing operations.

This position will serve as the quality guarantor, ensuring that leaner, faster processes also deliver safe, compliant, and high-quality products.

Responsibilities

• Quality Integration into process improvement projects
• Validation & Verification (processes and equipment)
• Risk Management and Mitigation
• Data Analysis and Metrics Tracking
• Lean Manufacturing Concepts Implementation
• Documentation Development, Procedures, and Training
• Regulatory Compliance & Auditing
• Cross-Functional Team Collaboration
• Project Planning and Management

Requirements

Experience

• Minimum 2+ years in a quality or engineering role within a regulated manufacturing environment
• Experience with lean manufacturing concepts and transformations
• Equipment and process validation experience
• Cost analysis experience
• Strong analytical problem-solving and communication skills (English & Spanish)

Additional Skills (Nice to Have)

• Agile / Lean manufacturing methodology

Education

• Bachelor's Degree in Industrial, Manufacturing, Mechanical, Electrical, or Chemical Engineering

*Willing to work 100% On-Site in Villalba.*