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Capa Engineer Ii Jobs

Qa Specialist Non-Conformance/Capa
By Astellas At , Sanford
Experience managing and improving Quality Management Systems and metrics
Experience with Quality Management Systems (Veeva, TrackWise, Veeva Quality Docs, etc.)
Perform other support responsibilities as requested to support Quality and Compliance activities.
Proven ability to manage multiple projects while maintaining quality
Strong interpersonal skills with reputation for collaboration with colleagues
Strong computer skills including MS Office (Word, Excel, PowerPoint, MS Project)
Capa Coordinator Jobs
By Advanced Clinical At Kent County, DE, United States
Must be a team collaborator, have exceptional organizational and time management skills, and be proficient with applicable software systems.
This is a remote position that be worked from home anywhere in the United States or Europe***
Lead the overall administration, tracking and management of Noncompliances and CAPAs at Advanced Clinical
Provide support to Compliance and Quality Management and Operations Quality teams
Provide training on the Noncompliance, CAPA and effectiveness check process/requirements to company staff
Certification: Has or will obtain within one year of hire at least one relevant certification (CQA, RQAP, RAC, etc.)
Capa Process Analyst Jobs
By Intellectt Inc At San Diego, CA, United States
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.
Capa Analyst Jobs
By Intellectt Inc At San Diego, CA, United States
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.
Capa Engineer Ii Jobs
By Abbott At Alameda, CA, United States
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.