Quality Engineer - R&D, Medical Devices

QA

Bar-Lev

Position 1033

Job Description:

• Quality System Compliance: Ensure compliance with global regulatory requirements and standards for medical devices, including FDA QSR, ISO 13485, EU MDR, and others as applicable.
• Design Control & Risk Management: Participate in design control activities, ensuring quality considerations are integrated into product development processes. Lead risk management activities (FMEA, risk analysis) to identify and mitigate potential issues.
• Process Validation and Verification: Oversee the validation and verification of design and manufacturing processes. Ensure robust testing methodologies are applied to prove that designs meet all requirements and regulations.
• Documentation and Records: Write and Maintain comprehensive documentation that meets regulatory and company requirements throughout the product development lifecycle. Ensure traceability and accessibility of quality records.
• Cross-functional Collaboration: Work closely with R&D, manufacturing, regulatory affairs, and other departments to ensure quality is embedded in all aspects of product development and production.
• raining and Development: Provide quality engineering expertise and training to R&D and other teams. Stay updated on industry trends, regulatory changes, and best practices in quality management.

Requirements:

• Bachelor's degree in Engineering, Quality Assurance, or related field.
• Minimum of 3-5 years of experience in quality engineering within the medical device industry.
• Solid understanding of medical device regulations (FDA QSR, ISO 13485, EU MDR).
• Experience with design control, risk management, and process validation principles.
• Strong analytical, problem-solving, and project management skills.
• Excellent communication and teamwork abilities.
• Certification as a Quality Engineer (CQE) or similar is preferred.