Quality Engineer II - Validation

Weil Group • Juncos, PR

9h

About The Position

We are looking for a skilled and driven Quality Engineer to develop, implement, and maintain quality standards and procedures across the manufacturing process. This role ensures that products and processes meet internal and external requirements, including regulatory compliance and customer expectations.

Requirements

• Bachelor’s degree in Engineering or a related field.
• Minimum of 4 years of relevant experience in quality or manufacturing engineering with process and CSV validation; or an advanced degree with equivalent experience.
• Knowledge of quality systems, Six Sigma, root cause analysis, statistical tools, and regulatory requirements (e.g., FDA, ISO, cGMP).

Responsibilities

• Develop, modify, and maintain quality protocols for materials processing and product manufacturing.
• Collaborate with engineering, manufacturing, and supply chain teams to ensure quality standards are integrated into all processes.
• Create and implement inspection and testing procedures for evaluating the precision and performance of products and equipment.
• Design and specify testing mechanisms, inspection tools, and quality assurance protocols.
• Perform data analysis and statistical evaluations to identify trends and root causes of quality issues.
• Lead corrective and preventive action (CAPA) processes and ensure long-term resolution of non-conformities.
• Ensure all documentation meets regulatory and internal standards, including FDA, ISO, and cGMP where applicable.
• May specialize in areas such as design quality, supplier quality, production quality, or product reliability.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 1-10 employees