Lead Specialist, Quality Engineer

at  GE Healthcare

JOB DESCRIPTION SUMMARY

We are looking for a Lead Specialist, Quality Engineer. The Lead Specialist, Quality Engineer is responsible for providing process support for our engineering teams in accordance with our procedures & practices. This is a key technical role responsible for the continuous development, implementation and reinforcement of our quality assurance practices. Lead Specialist, Quality Engineer is also a core member in design development teams engaged in development and production of high-quality medical device systems.

QUALIFICATIONS AND EXPERIENCE

• Bachelor’s Degree or advanced degree
• Experience in Quality Assurance, Quality Engineering or Design Engineering in medical device industry
• Demonstrated understanding of Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820 and ISO 13485
• Demonstrated understanding of medical device design controls requirements
• Demonstrated understanding of software development lifecycle, software design change, software process verification and validation methodologies
• Demonstrated knowledge of Quality and Process Improvement tools
• Ability to communicate effectively in English

DESIRED SKILLS

• Strong technical aptitude
• Ability to handle tasks with competing priorities effectively
• Demonstrated collaboration and conflict resolution skills
• Analytical, problem solving and root-cause analysis skills
• Leader with energy, passion and enthusiasm to drive change

ELIGIBILITY REQUIREMENTS

Valid local work permit

• Ensures quality and regulatory compliance in accordance with documented procedures
• Leads development and implementation of strategy to ensure compliance and product quality
• Ensures process efficiency and compliance
• Drives, influences and supports continuous process improvement
• Drives, influences and supports continuous product quality improvement
• Supports CAPA process
• Performs internal audits and supports external audits