Lead Design Control Engineer

Описание

This role manages 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.

Responsibilities

• Responsible for compliance across Ultrasound business
• 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
• 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

Requirements

• 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
• 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
• 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
• 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

Nice to have

• Lean Certification

We offer

• Relocation Assistance Provided: No
• Our salary and benefits are everything you'd expect from an organization with global strength and scale
• You'll be surrounded by career opportunities in a culture that fosters care, collaboration and support