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DHF Remediation Engineer
Cyient
Evaluate and improve Design History Files for regulatory compliance.
4d ago
Junior (1-3 years)
Full Time
Pune, Maharashtra, India
Onsite
Company Size
12,733 Employees
Service Specialisms
Engineering
Digital Solutions
Consulting Services
Managed Network Services
Application Development
Sector Specialisms
Communications
Medical Devices
Life Sciences
Rail
Utilities
Telecommunications
Internet of Things (IoT)
Smart City
Role
What you would be doing
dhf remediation
risk analysis
compliance review
audit assessments
documentation management
stakeholder collaboration
- Utilize analytical skills to identify root causes of DHF issues and implement robust solutions, developing creative strategies to address complex documentation challenges.
- 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.
- 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.
- Evaluate and improve Design History Files (DHFs) to ensure compliance with regulatory requirements, identifying gaps and implementing corrective actions.
- Ensure completeness, accuracy, and accessibility of all DHF documentation, including design controls, specifications, verification and validation reports, and risk management files.
- 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.
- 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.
- 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.
- 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.
What you bring
2-6 years
dhf
medical device
regulatory
project management
communication
- 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.
Information not given or found
Training + DevelopmentInformation not given or found
Interview process
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Visa SponsorshipInformation not given or found
Security clearanceInformation not given or found
Company
Overview
$879M FY2024 Revenue
Annual Financial Performance
Achieved significant revenue milestone, showcasing strong financial growth and market impact.
20+ Strategic Acquisitions
Expansion Through Acquisition
Built leadership through transformative acquisitions in plant engineering, wireless tech, and semiconductors.
- Rebranded from IT to intelligent engineering and tech solutions, shifting focus in 1991.
- Operates globally with delivery centers across North America, Europe, Asia-Pacific, and Australia.
- Provides advanced services including digital transformation, CAD/CAE, geospatial services, embedded systems, and turnkey semiconductor design.
- Specializes in heavy-industry collaborations with aerospace, energy, transportation, utilities, and semiconductor clients.
- They believe in doing the right thing, even when no one is looking.
- They embrace change and constantly look for better ways to solve problems.
- They deliver quality work and always strive for continuous improvement.
- They work as one team, across functions and geographies, to achieve success.
- They put their customers at the heart of everything they do, anticipating their needs.
- They take ownership of their actions and outcomes.
2040
Net Zero Commitment
Aims to achieve net zero carbon emissions, showcasing a long-term sustainability vision.
- Aims to reduce its carbon footprint through energy efficiency, renewable energy adoption, and sustainable operations.
- Has implemented several green initiatives, including eco-friendly office spaces and waste management programs.
- Tracks and reports its environmental impact through regular audits and public sustainability disclosures.
30% by 2025
Gender Diversity Goal
Target percentage for gender diversity in the workforce by the specified year.
- Focuses on creating an inclusive environment that promotes equal opportunities for all employees.
- Annually reports on gender diversity and inclusion metrics across various leadership and functional roles.
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