Quality Complaints & CAPA Specialist

qualityconsultinggroup; Juncos (PR); On-site; USD 60,000 - 90,000; Full time

Job summary

Quality Consulting Group, LLC is seeking a skilled professional to lead product complaint investigations in a world-class manufacturing setting across Puerto Rico and the USA. The role requires strong data analysis, CAPA determination, and excellent documentation to communicate findings clearly to non-technical reviewers.

Candidates should have a Bachelor’s degree and at least five years of related experience, with a proven quality mindset and proficiency in Microsoft Office and Teams.

Qualifications

• Bachelor's degree in related area.
• Five years of directly related experience.
• Experience in project management, root cause analysis, and CAPA.
• Strong quality mindset with comprehensive knowledge of quality systems, cGMP, and regulatory requirements.
• Proficiency with Microsoft Office, including Excel and Outlook, and Teams.

Responsibilities

• Support the product complaint system; lead investigations and data analysis to detect signals.
• Keep the complaints database updated and summarize closed investigations.
• Ensure investigations are concise, clear, and science-based.
• Follow up on corrective actions through completion.
• Communicate complaints and issue closure letters to patients and business partners.
• Operate in a GMP, matrix-managed environment and demonstrate problem-solving and customer service skills.

Skills

CAPA

Root cause analysis

Project management

cGMP

Excel

Communication

Problem-solving

Education

Bachelor's degree in related area

Tools

Microsoft Office Suite

Microsoft Teams

Excel

Job description

Quality Consulting Group, LLC is seeking a skilled professional to lead product complaint investigations in a world-class manufacturing setting across Puerto Rico and the USA. The role requires strong data analysis, CAPA determination, and excellent documentation to communicate findings clearly to non-technical reviewers.

Candidates should have a Bachelor’s degree and at least five years of related experience, with a proven quality mindset and proficiency in Microsoft Office and Teams.