Quality Engineer II
Core
Develops, modifies, applies, and maintains quality standards and protocols for processing materials into finished products in FDA/ISO-regulated environments.
Role type
Quality Engineer II (Manufacturing/Quality Assurance)
Builds
Quality assurance systems, inspection/testing mechanisms, and compliant documentation for pharmaceutical, biotechnology, medical devices, and food industries.
Domain
Life Sciences Manufacturing / Quality Engineering
Required skills
GMP compliance, CAPA management, change control, document control, risk management, validation (IQ/OQ/PQ), statistical analysis (SPC, DOE, capability analysis), FMEA, 5 Whys, Fishbone, Lean Six Sigma
Preferred skills
Mechanical/Industrial/Electrical Engineering degree, FDA/ISO-regulated environment experience, automation/programming experience, Lean Six Sigma certification
Technologies
Minitab, JMP, Excel, Power BI, SAP
Responsibilities
Design or specify inspection and testing mechanisms and equipment; conduct quality assurance tests; perform statistical analysis to assess non-conformance; ensure corrective measures meet reliability standards; collaborate with engineering and manufacturing functions to ensure quality standards are in place.
Seniority
Mid-level Individual Contributor