CAPA SME

CAPA Remediation Consultant

We are seeking a CAPA subject matter expert to support a large-scale FDA remediation initiative within a regulated medical device environment. This consultant will review approximately two years of CAPA data, assess existing records for compliance gaps, lead investigations, and drive remediation activities related to FDA 483 observations and ongoing quality system improvements. Candidates must be able to work independently, engage cross-functional stakeholders, and provide immediate value with minimal supervision.

The ideal candidate will have deep experience in CAPA management, FDA inspection response, root cause investigations, and quality systems within the medical device industry.

Responsibilities include identifying deficiencies in CAPA files, facilitating investigations with SMEs, applying root cause methodologies such as 5 Whys and Fishbone Analysis, developing corrective actions, and supporting warning letter remediation efforts. Prior experience with FDA 483 remediation is highly preferred.

Medical device experience is required, preferably with Class II products, and additional pharmaceutical quality systems experience is a strong plus.

Candidates should have a proven track record of successful CAPA remediation, quality systems leadership, FDA compliance, and inspection readiness in highly regulated environments.

Preference will be given to remote candidates located on the East Coast, specifically in the Northeast

Please note, we cannot provide sponsorship for candidates