Corrective Action Preventive Action (CAPA) Specialist

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

Corrective Action Preventive Action (CAPA) Specialist

Pinnaql is a trusted consulting partner to regulated life sciences companies, providing deep technical, validation, and quality expertise across every stage of the product lifecycle. We partner with pharmaceutical, biotech, and medical device organizations to navigate complexity, accelerate project timelines, and maintain a strong state of compliance and audit readiness.

We are seeking a qualified professional with hands‑on experience executing activities associated with Corrective and Preventive Actions (CAPA) and quality investigations within the medical device industry or a similar regulated manufacturing environment. The ideal candidate will support the investigation process, perform root cause analysis, and help develop and implement appropriate actions in accordance with established quality procedures.

Description:

• 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.

Qualifications:

• Bachelor’s degree in Engineering, Life Sciences, Chemistry, or a related discipline.
• At least 3 years of relevant experience supporting CAPA activities, quality investigations, or quality systems within the medical device, pharmaceutical, or another regulated manufacturing environment.
• Working knowledge of root cause analysis, nonconformance investigations, and corrective and preventive action processes.
• Strong analytical, documentation, communication, and problem‑solving skills.
• Ability to work on‑site in Puerto Rico.
• Occasional overtime may be required based on business needs; this is expected to be infrequent.
• Experience working within regulated quality systems and familiarity with applicable industry standards is highly desirable.

At Pinnaql, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose‑driven, supportive team.
Excited to build something meaningful together? We look forward to hearing from you.
Pinnaql is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.