Senior Medical Device Quality Assurance Engineer

About the role

We are seeking a hands‑on Senior Medical Device Quality Assurance Engineer to lead quality activities and support large‑scale production growth of our radiation‑protection devices. The role is based in Netanya and works closely with production, engineering, and supply‑chain teams to ensure compliance with regulatory and company standards.

Key responsibilities

• Lead change‑control projects, coordinating manufacturing, process, equipment, material and documentation changes.
• Provide QA oversight for validation activities, including equipment qualification (IQ/OQ/PQ), process validation, clean‑room qualification and validation protocol development.
• Conduct production risk assessments, ensuring risks are identified, evaluated, mitigated and aligned with manufacturing changes.
• Improve manufacturing work instructions to enhance clarity, compliance and efficiency.
• Support manufacturing scale‑up, transfer to higher volumes and implementation of new processes while maintaining quality compliance.
• Lead investigations of production non‑conformities, determine root causes and drive corrective and preventive actions.
• Monitor operational quality metrics and contribute to initiatives that improve product quality, yield and process performance.
• Collaborate with cross‑functional teams on continuous‑improvement projects.

Required profile

• Proven experience in quality assurance for medical‑device manufacturing.
• Strong knowledge of validation, qualification and risk‑assessment methodologies.
• Ability to lead cross‑functional projects and drive change.
• Hands‑on approach with solid investigative and problem‑solving skills.
• Familiarity with GMP/ISO 13485 regulatory environments.
• Excellent written and verbal communication for documentation and stakeholder interaction.

Required skills

• Equipment qualification (IQ/OQ/PQ).
• Process validation.
• Clean‑room qualification.
• Validation protocol and report development.
• Risk assessment and mitigation.
• Investigation and corrective‑preventive action management.
• Work instruction authoring and improvement.