Job Description Summary
The Design Control Lead Quality Engineer will manage quality systems, processes, and procedures to assure product safety, quality, and site compliance by driving business alignment to industry requirements for the Haifa PoC Ultrasound business.
Develop and maintain systems, rules, and processes to ensure fulfillment of internal and external requirements. Ensures that projects and products are capable and will meet specified standards (Preventive). In-depth understanding of key business drivers; uses this understanding to accomplish own work. In-depth understanding of how work of own team integrates with other teams and contributes to the area.
Job Description
Key responsibilities include:
Responsible for compliance across Ultrasound business – Design Controls
Strategic partner with supporting functions – Sourcing, Supplier Quality, and Service
Providing leadership and facilitates problem resolution, and mentoring of team members, including accountable to ensure, follow up, and/or implement corrective actions that are raised by deviations, internal audit, or regulatory inspection.
Creates a Quality culture by driving compliance activities for the Haifa PoC Ultrasound business. This includes being responsible for the total quality management system for the business and driving Quality metrics, including engaging strong intradepartmental and cross-functional/organizational relationships to drive Quality System Requirements (QSRs)
Drives execution for all key quality system metrics; Owns Quality Compliance Scorecard and facilitates appropriate operating mechanisms to ensure quality objectives are met.
Leads efforts regarding continuous improvements projects across Ultrasound Business
Qualifications :
Bachelor's Degree in a scientific discipline and a minimum of 5 years working experience in the medical device industry and/or 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 or aptitude to understand Medical Device QMS requirements and regulatory requirements including but not limited to FDA CFR 21 820 and ISO 13485.
Preferred Qualifications:
Demonstrated ability to develop & lead process implementation
Experience with all of the following:
Design controls, design verification and validation activities, SDLC, Design Transfer, Design changes
CAPA, complaints and risk management
Root Cause Analysis tools
Production and process controls
Experience conducting internal audits
Lean Certification is a plus
Demonstrated effective interpersonal and networking skills
Prior experience using word processing, spreadsheet, and presentation software
Demonstrated ability to successfully comprehend & carry out/execute actions
Effective oral and written communication skills
Analytical & problem-solving skills/root-cause analysis
Conflict-resolution skills
Ability to prioritize and drive multiple programs
Integrity: Accepting and adhering to high ethical, moral, and personal values in decisions, communications, actions, and when dealing with others
Accepting constructive criticism and dealing calmly and effectively with high-stress situations. This includes continuing to persevere and remaining calm in challenging or frustrating circumstances
Energizing others by building a connection with the team through personal involvement and trust and providing feedback and coaching to help develop others
Simplifying strategy into specific actions with clear accountability, making decisions with speed and accuracy based on best available information, and communicating priorities clearly and concisely
GE HealthCare 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…