Quality Engineer II - Validation

Weil Group, Inc; Juncos (PR); On-site; USD 70,000 - 90,000; Full time

Job summary

A manufacturing firm is seeking an experienced Quality Engineer in Juncos, Puerto Rico. In this role, you will develop and implement quality standards, ensuring compliance with regulatory requirements such as FDA and ISO. The ideal candidate has at least 4 years of relevant experience in quality or manufacturing engineering and is proficient in statistical analysis and problem-solving. This position offers an opportunity to contribute to cross-functional teams and improve overall quality performance.

Qualifications

• Minimum of 4 years of relevant experience in quality or manufacturing engineering.
• Experience with process and CSV validation is necessary.
• Knowledge of FDA, ISO, and cGMP requirements.

Responsibilities

• Develop and maintain quality protocols for materials processing.
• Collaborate with teams to integrate quality standards into processes.
• Perform data analysis to identify trends in quality issues.
• Lead corrective actions to ensure resolution of non-conformities.

Skills

Quality standards development

Statistical analysis

Regulatory compliance

Cross-functional collaboration

Root cause analysis

Problem-solving

Education

Bachelor’s degree in Engineering or a related field

Tools

Six Sigma

Job description

Job Title: Quality Engineer - Validations Experience a must

Position Summary:

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.

Key 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.

Career Track: Specialist

• Functions as an individual contributor with subject matter expertise in quality engineering.
• Manages assigned projects from planning through execution, collaborating with stakeholders to achieve results.
• May mentor junior engineers or serve as a technical resource to cross‑functional teams.
• Applies professional judgment and technical skills gained through formal education and hands‑on experience.

Differentiating Factors:

• Autonomy: Works independently on moderately complex assignments with general supervision.
• Impact: Contributes to project milestones and quality targets; may be involved in cross‑functional initiatives.
• Problem Solving: Addresses common quality issues and proposes enhancements to systems and processes to improve performance.
• Communication: Frequently interacts with internal teams to share updates, provide input, and support decision‑making.
• Mentorship: May guide and support entry‑level professionals or technicians.
• Qualifications:
• 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).

Weil Group is proud to be an Equal Employment Opportunity Employer.