CAPA & Quality Investigation Specialist (Medical Devices)

Validation & Engineering Group, Inc.; Aibonito (PR); On-site; USD 70,000 - 100,000; Full time

Job summary

Pinnaql is seeking a qualified professional to support CAPA activities and quality investigations in a regulated medical device environment. You will participate in root cause analysis, help define corrective actions, and maintain precise investigation records.

The role emphasizes collaboration with Quality Assurance, Manufacturing, and Engineering to ensure timely completion of actions and adherence to procedures and regulatory expectations. On-site work in Puerto Rico is required.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, Chemistry or related discipline.
• At least 3 years supporting CAPA activities, quality investigations, or quality systems in regulated manufacturing.

Responsibilities

• Execute CAPA records and quality investigations; gather info and document findings.
• Perform root cause analysis to identify underlying causes of deviations and quality issues.
• Support identification, definition, and implementation of corrective and preventive actions.
• Prepare CAPA reports and investigation documentation; maintain quality records.
• Assist with follow-up to verify action implementation and effectiveness checks.

Skills

CAPA execution

Root cause analysis

Quality investigations

Documentation

Regulatory awareness

Education

Bachelor’s degree in Engineering/Life Sciences/Chemistry

Tools

Quality systems

Job description

Pinnaql is seeking a qualified professional to support CAPA activities and quality investigations in a regulated medical device environment. You will participate in root cause analysis, help define corrective actions, and maintain precise investigation records.

The role emphasizes collaboration with Quality Assurance, Manufacturing, and Engineering to ensure timely completion of actions and adherence to procedures and regulatory expectations. On-site work in Puerto Rico is required.