Lead Quality Engineer

Job Description Summary
The 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.

Job Description

Key responsibilities include:

Responsible for compliance across Ultrasound business– Management Controls, Design Controls and CAPA; Strategic partner with supporting functions – Engineering, Program, Product, Sourcing, Supplier Quality, Production 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
CAPA, complaints and risk management
Root Cause Analysis tools
Production and process controls
Experience conducting internal audits preferred
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

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Additional Information

The job is open to men and women equally

Relocation Assistance Provided: No