Design Quality Leader- NPI

Responsibilities

• Act as design control SME: lead the quality design control process, from design inputs through verification, validation, and smooth design transfer, ensuring rigorous adherence to regulatory and quality standards
• Validates critical design inputs such as usability, reliability, performance, manufacturability, and safety, ensuring alignment with both quality standards and regulatory requirements.
• Guides comprehensive risk management activities throughout the product lifecycle, ensuring potential risks are accurately identified, assessed, and effectively mitigated to uphold product safety and quality. Participating in device risk management activities including UFMEA, DFMEA, PFMEA.
• Reviewing and approving V&V, protocols and reports to meet regulatory compliance and procedures
• Supporting activities related to Design Transfer: plan and execution
• Lead the design review meetings: planning, data gathering and review for compliance, meeting reviews reports.
• Keeps a check on the drafting and updating of detailed DHF, DMR documents, ensuring all documentation is accurate, up-to-date, and compliant with regulatory requirements.
• Leverages post-market performance data to assess product effectiveness in the field, providing actionable feedback to manufacturing and design teams, and initiating corrective actions when necessary.
• Support internal and external audits, resolutions of gaps towards continuance improvements 
• Builds effective relationships with internal and external stakeholders, providing guidance and mentorship to ensure alignment with quality standards and project milestone

Qualifications

• Bachelor’s degree in engineering, biotechnology, chemistry, or a related field (or equivalent relevant experience).
• >7 years of experience in Quality Assurance.
• Knowledge of ISO 13485, 21 CFR Part 820, or quality systems in regulated industries.
• Experienced in writing and maintain quality documents.
• Strong attention to details, problem-solving skills, and a willingness to learn.
• Excellent written and verbal communication skills in English.
• Ability to work collaboratively in a team environment manage time effectivly.

Location: Haifa