Responsibilities:

• Lead the development and review of validation protocols for design verification and validation (V&V), Excel files, and processes, ensuring compliance with all relevant standards and regulations.
• Evaluate processes and equipment to guarantee adherence to regulatory and quality requirements.
• Review validation plans, test results, and summary reports for regulatory compliance.
• Provide expert guidance on quality and regulatory requirements for validation activities, encompassing production, manufacturing, user requirements specifications, and testing strategies.
• Offer cross-departmental support to ensure adherence to ISO 13485, FDA requirements, and other applicable quality and validation regulations. This includes conducting standards gap assessments.
• Possess a deep understanding of validation and technical issues, allowing you to effectively assess their potential impact on product quality.
• Evaluate the impact of validations as part of the change control process.
• Implement robust quality assurance monitoring of projects to ensure regulatory compliance of validation and design processes.
• Maintain the device risk management file and associated traceability matrices.
• Actively participate in cross-functional teams to define validation strategies and objectives that align with organizational needs.
• Work collaboratively with design teams to select new equipment that supports successful validation efforts.

Qualifications:

• 4-7 years of experience within a medical device company
• Strong understanding of medical device standards and experience in qualification documentation review
• Bachelor’s degree in Biomedical or Biotechnology Engineering (preferred)
• Experience in data analysis (a plus)
• Strong technical and engineering knowledge (a plus)
• Excellent written and verbal communication skills in both Hebrew and English
• A team player with exceptional communication and collaboration skills