V&V and QA Engineer

Located in Hod HaSharon.

Temporary position for 5 months.

Key Responsibilities:

*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

*Coordinate and manage V&V tests at external laboratories (such as *Cleaning, Safety, EMC, transportation, etc.)

Required Qualifications:

*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