DHF Remediation Engineer
- Pune, Maharashtra
- Permanent
- Full-time
- Evaluate and improve Design History Files (DHFs) to ensure compliance with regulatory requirements, identifying gaps and implementing corrective actions.
- Conduct detailed audits and assessments of existing DHFs to identify non-conformances and areas for improvement, ensuring alignment with current regulations and standards, such as FDA and ISO 13485.
- Ensure completeness, accuracy, and accessibility of all DHF documentation, including design controls, specifications, verification and validation reports, and risk management files.
- Collaborate with R&D, Quality Assurance, Regulatory Affairs, and other relevant teams to gather necessary information for DHF updates and improvements, facilitating effective communication among stakeholders.
- Stay updated on current regulatory requirements and industry best practices related to medical device documentation and design controls, providing training and guidance to team members on DHF requirements and remediation processes.
- Support risk management processes by integrating relevant risk analysis and mitigation strategies into DHF documentation, collaborating on development and updates to the product Risk Management File.
- Utilize analytical skills to identify root causes of DHF issues and implement robust solutions, developing creative strategies to address complex documentation challenges.
- Lead DHF remediation projects, ensuring timely completion of tasks and adherence to project timelines, and reporting project status, challenges, and achievements to management and stakeholders.
- Conduct thorough reviews and validation of DHF and associated documentation to ensure compliance with quality standards, supporting audits and inspections by regulatory bodies with organized and accurate DHF documentation.
- 2-6 years of experience in DHF preparation or remediation in the medical device industry, and demonstrate strong understanding of regulatory standards and requirements, excellent organizational, project management, and communication skills.