CAPA & Quality Investigator – Medical Devices (Onsite PR)

Validation-; Aibonito (PR); On-site; USD 65,000 - 90,000; Full time

Job summary

Pinnaql is seeking a CAPA Specialist to support quality investigations in a regulated medical device environment in Puerto Rico. You will execute CAPA records, perform root cause analysis, and help implement corrective and preventive actions.

Collaborate with QA, manufacturing, and engineering to ensure timely completion of activities, document findings, and verify effectiveness. This on-site role may require occasional overtime based on business needs.

Qualifications

• CAPA activities and quality investigations experience.
• Working knowledge of root cause analysis and corrective/preventive actions.
• Experience in regulated manufacturing environments (medical device/pharma).
• Strong documentation, communication, and problem-solving skills.
• Ability to work on-site in Puerto Rico.

Responsibilities

• Execute activities associated with CAPA records and quality investigations, including gathering information, reviewing documentation, and documenting findings.
• Conduct root cause analysis to identify the underlying causes of deviations, nonconformances, and other quality issues.
• Support the identification, definition, and implementation of corrective and preventive actions.
• Prepare and maintain accurate investigation reports, CAPA documentation, and supporting quality records.
• Assist with follow-up activities to verify action implementation and document effectiveness checks, as applicable.
• Collaborate with Quality Assurance, Manufacturing, Engineering, and other cross-functional teams to support timely completion of assigned activities.
• Ensure work is performed in accordance with established procedures, quality system requirements, and applicable regulatory expectations.

Skills

Root cause analysis

Nonconformance investigations

CAPA processes

Analytical skills

Documentation

Communication

Problem-solving

Education

Bachelor’s degree in Engineering, Life Sciences, Chemistry, or a related discipline

Job description

Pinnaql is seeking a CAPA Specialist to support quality investigations in a regulated medical device environment in Puerto Rico. You will execute CAPA records, perform root cause analysis, and help implement corrective and preventive actions.

Collaborate with QA, manufacturing, and engineering to ensure timely completion of activities, document findings, and verify effectiveness. This on-site role may require occasional overtime based on business needs.