Lead Specialist, Quality, PPC Quality Engineer

As the Lead Quality Engineer, you will be responsible for providing manufacturing and/or engineering process support in accordance with documented procedures and practices. This is a key technical role responsible for the development, implementation, improvement and continuous reinforcement of established Quality Management System practices, product specifications and applicable standards. You will collaborate within the areas of design, design transfer, manufacturing, distribution, and service.

GE Health Care is a leading global medical technology and digital solutions innovator. Our mission is to improve lives in the moments that matter. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.

• Creates a Quality culture by driving compliance activities around a specific product, site or region. This includes being responsible for the quality management system for the business and driving Quality metrics.
• Ensures quality and regulatory compliance while driving process effectiveness and efficiency through the implementation of lean processes and standard work.
• Represents GE Healthcare to external agencies and champions the evolution of the quality culture which includes executing and driving quality objectives, metrics, reporting and operating mechanisms.
• Serves as best practice/quality resource. Contributes towards strategy, process development, and ensures delivery within area of responsibility.
• Skilled influencer, able to communicate complex messages to others. Collaborates with colleagues in Quality and internal customers. May lead projects with moderate risks and resource requirements.
• Uses judgment to make decisions or solve moderately complex tasks or problems. Takes new perspective on existing solutions. Uses technical experience and expertise for data analysis to support recommendations.
• Leads process efficiency and compliance effectiveness through the development and implementation of equipment qualification and process validation, including Master Validation Plans (Site Level), Validation Master Plans (Product or Process specific plans), and the development of detailed process flow diagrams that describe critical process interdependencies with respect to process inputs, outputs, risks, and impacts. Utilizes risk management tools including but not limited to pFMEA/dFMEA.
• Supports continuous product and process improvement through detailed failure analysis for non-conformances, and investigates, develops and implements effective and compliant solutions for product or process corrections, retrospective and remediation action plans, and for corrective and preventive actions (CAPA Program).

• Bachelor's degree from an accredited university/college or a minimum of 6 years of relevant work experience in Medical Devices, or similar regulated industry.
• Minimum of 3 years of experience working in a regulated industry.
• Ability to communicate effectively in English (both written and oral).
• Demonstrated experience and proficiency with MS Office word processing, spreadsheet, presentation, and database applications.

• Demonstrated understanding of Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820 and ISO 13485.
• Experience in Quality Assurance, Quality Engineering, Design Engineering or Manufacturing Engineering in a regulated industry.
• Demonstrated expertise to effectively communicate within different functions and different levels of the organization around QMS concepts including Production & Process Controls, Corrective & Preventive Action (CAPA), Risk Management and Product Quality.
• Demonstrated collaboration, negotiation, and conflict resolution skills.
• Experience performing internal audits and participating in external audits.
• Demonstrated understanding of design change, document change control and manufacturing/production process change control processes and methodologies.
• Ability to demonstrate analytical, problem solving & root-cause analysis skills along with…