Lead Manufacturing Quality Engineer
Core
Oversee quality assurance for new product delivery and drive continuous improvement for mature products, ensuring compliance with regulatory standards and safety throughout the lifecycle.
Role type
Lead Manufacturing Quality Engineer
Builds
Consumer electronics and technology products
Domain
Manufacturing quality engineering and regulatory compliance
Required skills
Quality management systems (ISO 9001, ISO 13485, FDA 21 CFR Part 820), Risk management (FMEA, Design Risk), Problem solving (8D, Root Cause Analysis), Supplier quality management, Process validation, Reliability engineering, Project management (PMP)
Preferred skills
Six Sigma, SPC, APQP, DfX methodologies, Consumer electronics industry experience
Technologies
ISO 9001, ISO 13485, FDA 21 CFR Part 820, IEC60335, FMEA, 8D, SPC, APQP, PMP
Responsibilities
Lead quality assurance activities for new products ensuring regulatory compliance; Drive continuous improvement initiatives for mature products; Manage relationships with Contract Manufacturers and second-tier suppliers; Lead quality-related problem solving and root cause analysis; Represent the Quality team in project leadership and design reviews; Provide training and support to staff on quality practices and audit preparation
Seniority
Senior, hands-on IC