Engineer, Quality Assurance CAPA III
Core
Manage the resolution of exception reports (NCRs, PRAs) and audits to ensure compliance with GMPs and company regulations, acting as a Subject Matter Expert (SME) in quality system events.
Role type
Senior Quality Assurance Engineer (CAPA)
Builds
Documentation for investigation outcomes, containment, correction, and prevention actions
Domain
Medical device manufacturing / Quality Management Systems (ISO 13485)
Deliverable
client delivery
Required skills
CAPA management, NCR resolution, audit response, root cause analysis, process optimization, EHS compliance, resource prioritization
Preferred skills
ISO 13485 Lead Auditor, Data and Statistical Analytics
Technologies
None stated
Responsibilities
Review and approve documents derived from exception reports; Act as SME in working sessions for quality system events; Guide the NCR or audit process; Manage and prioritize resources for action implementation; Explain exception documents during external or internal audits; Continuously improve processes and documentation related to the Quality System; Ensure compliance with corporate and legal EHS requirements.
Seniority
Senior, hands-on IC