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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.Job Description
Responsibilities
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
Qualifications and experience
Bachelor’s Degree or advanced degree (or equivalent)
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
Inclusion and Diversity
GE Healthcare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.
Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.
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Additional Information
Relocation Assistance Provided: No
