1. 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.
2. 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.
3. 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.
4. 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
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.
? Personal Attributes:
Detail-oriented with a commitment to excellence.
Proactive in identifying issues and developing innovative solutions.
Ability to thrive in a fast-paced, collaborative environment.
Passionate about improving patient care through quality excellence.
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