Document Control Specialist
Bangalore, India
Quality & Regulatory /
Full Time /
Hybrid
Company Overview:
- At iSchemaView/RapidAI, we believe in leveraging cutting-edge technology and research to impact millions of lives. Our software products enhance doctors’ capabilities across hospitals worldwide to respond to and make the best decisions for patients quickly. We are looking for a high-energy employee who is excited to be at the forefront of medical device software development. The successful candidate will meet the criteria defined below, and in doing so, will help deliver the best patient care to patients all around the world.
Position Duties And Responsibilities
- Document Management:
- Maintain, organize, and manage the electronic document management system (eDMS) to ensure all controlled documents are current and accessible.
- Oversee the creation, revision, approval, and archival of quality documents, including Standard Operating Procedures (SOPs), work instructions, design control documents, and records.
- Ensure adequacy of company standard operating procedures (SOPs) to internal and external regulatory standards.
- Prepare and present quality-related content and reports to Quality management.
- Compliance and Audits:
- Ensure documentation complies with applicable quality system standards (e.g., ISO 13485, GMPs,etc).
- Prepare for and support internal and external audits, including regulatory inspections, by providing accurate and timely documentation.
- Change Control:
- Manage document change control processes, including logging, tracking, and facilitating timely approval of changes.
- Ensure proper documentation of change requests, justifications, and associated risks.
- Collaboration:
- Work closely with cross-functional teams (e.g., R&D, Quality Engineering, Regulatory, IT) to ensure accurate and consistent documentation practices, i.e. GDPs.
- Provide training to employees on document control policies, procedures, andls.
- Record Retention:
- Establish and maintain document retention schedules in compliance with regulatory and company requirements.
- Safeguard sensitive information to ensure data integrity and confidentiality.
- Process Improvement:
- Identify opportunities for improving document control workflows and implement best practices to enhance efficiency and compliance.
- Assist in the development and implementation of document management policies and procedures.
- Implement and improve established quality standards and metrics.
- This position does not have direct reports.
- This position will be based in Bengaluru, India.
- Perform any other related activities assigned by the reporting manager.
Education, Experience & Qualification
- Bachelor’s degree in a relevant field (e.g., Quality Management, life sciences, engineering, or related discipline).
- Minimum 2–4 years of experience in document control, quality assurance, or a related role in the medical device [JR1] industry.
- Familiarity with regulatory standards regarding documentation.
