Senior Quality Engineer
Core
Lead investigations of non-conformances, implement corrective and preventive actions, and ensure compliance with quality management systems in a regulated manufacturing environment.
Role type
Senior Quality Engineer
Builds
compliant medical devices and processes
Domain
Medical Device Manufacturing (via careerplan.io/jobs/R567778-senior-quality-engineer-at-stryker)
Required skills
non-conformance investigation, corrective and preventive action (CAPA), audit support, containment management, quality data analysis, FMEA, regulatory compliance
Preferred skills
internal/external audit execution, risk assessment, regulated manufacturing experience, statistical analysis tools
Technologies
FMEA, 21 CFR Part 820, ISO 13485, MDSAP
Responsibilities
Lead investigations of non-conformances and implement corrective and preventive actions; Collaborate with Engineering and Production teams to meet quality requirements; Support internal and external audits; Manage containment activities for non-conforming product; Monitor and trend quality data to identify risks and improvement opportunities; Ensure compliance with Quality Management System and regulatory requirements
Seniority
Senior, hands-on IC