Lead Design Control Engineer
Read straight from GE HealthCare's careers page, verified 2d ago.Seekless can tailor your résumé to it.
Seekless can write your résumé for this posting first.
Before you apply
LocationHaifa
Typefull-time
SeniorityLead
Experience5+ yrs
DepartmentQuality
Company size10,000+ people
PostedOct 25, 2026 · 1w ago
Verified live2d ago
At a glanceSummarised by Seekless from the posting.
Bachelor's Degree in a scientific discipline
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
Demonstrated ability to develop & lead process implementation
Experience with design controls, design verification and validation activities, SDLC, Design Transfer, Design changes
Experience with CAPA, complaints and risk management
Experience with Root Cause Analysis tools
Experience with 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
Skills
MS Office
word processing
spreadsheet
presentation
database
FDA CFR 21 820
ISO 13485
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 Ultrasoundbusiness. 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