Capa Lead Jobs in California

Demonstrates commitment to the development, implementation and effectiveness of ARDx Quality Management System per ISO, FDA, and other regulatory agencies.

Provide ongoing support to Quality management during external audits.

Manage the archival and handling of scanned CAPA records.

Critical Review of documents. Experience in assessing the weight of evidence associated with a claim/hypothesis/assertion is preferred.

Provide site administration of the CAPA program and support process owners in completing CAPAs and related business items.

Support and guide the Corrective Action Review Board and Users regarding the CAPA process, CAPA record content, and CAPA software.

Demonstrates commitment to the development, implementation, and effectiveness of ARDx Quality Management System per ISO, FDA, and other regulatory agencies.

Provide ongoing support to Quality management during external audits.

Excellent organization skills must be able to manage a large number of simultaneous projects

Manage the archival and handling of scanned CAPA records.

Critical Review of documents. Experience in assessing the weight of evidence associated with a claim/hypothesis/assertion is preferred.

Bachelor's degree, or the equivalent 1-2 years' experience in a FDA-controlled environment.

Communicate confidently and effectively with all levels of management, peers and key stakeholders, including timely escalation of quality issues.

Collaborate with cross-functional teams using various methodologies (e.g. Six Sigma root cause analysis/problem solving skills).

Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments.

Minimum 2 years significant engineering and/or technical operational experience plus demonstrated competence.

Previous CAPA and/or quality assurance/engineering experience and demonstrated use of quality tools/methodologies.

Prior medical device experience preferred.