Senior Quality Engineer
Core
Provide end-to-end quality oversight and partnering to ensure alignment with stakeholders, customers, and patient expectations in a pharmaceutical manufacturing environment.
Role type
Senior Quality Engineer (Manufacturing)
Builds
Quality systems, compliance reports, and continuous improvement initiatives for injectable medicines.
Domain
Pharmaceutical manufacturing / Healthcare
Required skills
Quality system management, CAPA management, root cause analysis, GMP compliance, audit leadership, Lean Sigma, data analysis, documentation control, training delivery
Preferred skills
SAP, Power BI, ISO standards, medical device/pharmaceutical manufacturing experience, Lean principles
Technologies
SAP, Power BI, Microsoft Office
Responsibilities
Manage quality system platforms (OOS, deviations, change control, CAPA, Document Control), lead QA department meetings, conduct internal and shop floor audits, provide guidance on batch tracing and disposition, compile and analyze quality metrics, train QA staff on GMP topics, support Lean Sigma programs.
Seniority
Senior, hands-on IC