Lead Design Control Quality Engineer

About the role

The Design Control Lead Quality Engineer manages quality systems, processes and procedures to assure product safety, quality and site compliance for the Haifa PoC Ultrasound business. The role drives business alignment to industry requirements and develops and maintains systems, rules and processes that meet internal and external standards.

Key responsibilities

• Ensure compliance across the Ultrasound business for design controls
• Act as strategic partner with sourcing, supplier quality and service functions
• Provide leadership, facilitate problem resolution and mentor team members, including follow-up and implementation of corrective actions from deviations, internal audits or regulatory inspections
• Create a quality culture and own the total quality management system, driving quality metrics and QSRs
• Own the Quality Compliance Scorecard and drive continuous improvement projects across the Ultrasound business

Required profile

• Bachelor's degree in a scientific discipline
• Minimum 5 years of experience in the medical device industry and/or a regulated industry
• Effective written and spoken English
• Understanding of Medical Device QMS and regulatory requirements such as FDA CFR 21 Part 820 and ISO 13485

Required skills

• Proficiency with MS Office word processing, spreadsheets, presentations and databases
• Preferred: design controls, design verification and validation, SDLC, design transfer, CAPA, complaints and risk management, root cause analysis, production and process controls, internal audits, Lean certification