Quality Engineer
Core
Driving quality adherence, process change, and risk assessment in a high-volume manufacturing facility to reduce internal and external non-conformances.
Role type
Quality Engineer (Manufacturing)
Builds
Validated production processes and quality control standards
Domain
Life Sciences / Pharma regulated manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
ISO 9001/ISO13485 compliance, Danaher Business System tools, Statistical Process Control (SPC), non-conformance investigation, corrective and preventive action (CAPA), data trending and analysis, procedure development, audit support, project management (CDTR), cost reduction program leadership
Preferred skills
Lean or DBS techniques, PSP practitioner, Quality accreditation/certification, Engineering Degree
Technologies
Danaher Business System, SPC tools
Responsibilities
Facilitate compliance improvement within the value stream; ensure non-conformances are reported and investigations are supported; review production environments to identify non-conformities; coordinate failure investigations and CAPA; analyze reject data from production inspection and QC tests; validate and improve production processes and standards; support product development/transfer activities; review and develop departmental procedures; support external audits; manage complaint investigations; lead CDTR projects; support cost reduction programs; identify and implement improvement opportunities.
Seniority
Mid-level, hands-on IC
