QA Lead Engineer
Core
Lead quality assurance for electrical safety compliance, coordinate product inspections, and manage certification documentation for life sciences and biotechnology equipment.
Role type
QA Lead Engineer (Electrical Safety & Compliance)
Builds
Certified electrical safety-compliant medical and biotech equipment
Domain
Life sciences, diagnostics, and biotechnology
Deliverable
client delivery
Required skills
Project management, cross-functional leadership, electrical safety standards knowledge, audit coordination, design change management, ASME/CE certification support
Preferred skills
QA environment experience, continuous improvement initiatives
Technologies
CDR (Constructional Data Reports), ETL, UL, MET, ASME, CE
Responsibilities
Coordinate quarterly ETL, UL, and MET audits; Collaborate with certification bodies to maintain documentation; Work with Regulatory Compliance and Life Cycle Engineering on design changes; Ensure compliance with electrical safety standards; Support ASME certification projects and provide CE/Customer Engineer support.
Seniority
Senior, hands-on IC
