Located in Hod HaSharon.
Temporary position for 5 months!
Design, execute, and document verification and validation TEST protocols for products and processes, with the ability to maintain and cross-reference them with a risk analysis matrix.
Develop and maintain internal quality documents.
Performing validation and testing of hardware (mechanical, electronic, optical) for medical device prototypes and products
Collaborate with development teams to establish testing criteria and quality benchmarks
Monitor and analyze TEST data to identify trends and potential areas for improvement
Ensure compliance with industry standards and regulatory requirements
Review and approve TEST results
Manage and maintain quality management system documentation
Manage and maintain DMR documents
Define, select, maintain, and document TEST equipment
Requirements: Bachelor's degree in Engineering, Quality Assurance, or related technical field
3+ years of experience in verification and validation testing in a medical products company
Strong understanding of quality management systems, regulatory requirements, and applicable standards.
Excellent analytical and problem-solving skills
Strong attention to detail and organizational abilities
Proficiency in statistical analysis and quality control methods
Experience with TEST automation tools and quality management software
Strong documentation and technical writing skills in English
Experience with ISO 13485 standard
Experience with risk management methodologies
This position is open to all candidates.
