Quality Engineer
Core
Ensure product, process, and quality system compliance with standards and regulations for Dynabeads technology used in diagnostics and life sciences.
Role type
Quality Engineer (Regulated Industry)
Builds
Diagnostic tests, advanced cancer treatments, life science research products
Domain
Life Sciences / Medical Devices / Biotechnology
Required skills
GMP/GxP knowledge, ISO standards (9001, 13485), validation/qualification, CAPA, root cause analysis, risk assessment, deviation management, change control
Preferred skills
Pharmaceutical/medical device/biotech industry experience
Technologies
Quality systems software, Microsoft Office
Responsibilities
Ensure compliance with quality standards and regulatory requirements; Act as Design Compliance and Quality Lead in New Product Introduction (NPI) projects; Lead and support risk assessments and mitigation strategies; Support validation and qualification of instruments, software, processes, and methods; Investigate deviations, perform root cause analyses, and support CAPA; Provide quality expertise and guidance across functions.
Seniority
Mid-level (3+ years experience)