Document Control Specialist

RapidAI; United States; Remote; USD 60,000 - 100,000; Full time

Job summary

An established industry player is seeking a detail-oriented Document Control Specialist to enhance quality management in medical device software development. This role involves maintaining an electronic document management system, ensuring compliance with regulatory standards, and collaborating with cross-functional teams to improve documentation practices. The ideal candidate will have a Bachelor's degree and 2-4 years of relevant experience in quality assurance or document control. Join a forward-thinking company dedicated to impacting patient care globally, where your contributions will help shape the future of medical technology.

Qualifications

• 2-4 years of experience in document control or quality assurance in medical devices.
• Familiarity with ISO 13485 and GMP standards.

Responsibilities

• Maintain and manage the electronic document management system.
• Ensure compliance with quality system standards and support audits.
• Identify and implement process improvements in document control.

Skills

Document Management

Quality Assurance

Regulatory Compliance

Process Improvement

Cross-functional Collaboration

Education

Bachelor’s degree in Quality Management or related field

Job description

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

1. Document Management:
   1. Maintain, organize, and manage the electronic document management system (eDMS) to ensure all controlled documents are current and accessible.
   2. Oversee the creation, revision, approval, and archival of quality documents, including Standard Operating Procedures (SOPs), work instructions, design control documents, and records.
   3. Ensure adequacy of company standard operating procedures (SOPs) to internal and external regulatory standards.
   4. Prepare and present quality-related content and reports to Quality management.
2. Compliance and Audits:
   1. Ensure documentation complies with applicable quality system standards (e.g., ISO 13485, GMPs, etc).
   2. Prepare for and support internal and external audits, including regulatory inspections, by providing accurate and timely documentation.
3. Change Control:
   1. Manage document change control processes, including logging, tracking, and facilitating timely approval of changes.
   2. Ensure proper documentation of change requests, justifications, and associated risks.
4. Collaboration:
   1. Work closely with cross-functional teams (e.g., R&D, Quality Engineering, Regulatory, IT) to ensure accurate and consistent documentation practices, i.e. GDPs.
   2. Provide training to employees on document control policies and procedures.
5. Record Retention:
   1. Establish and maintain document retention schedules in compliance with regulatory and company requirements.
   2. Safeguard sensitive information to ensure data integrity and confidentiality.
6. Process Improvement:
   1. Identify opportunities for improving document control workflows and implement best practices to enhance efficiency and compliance.
   2. Assist in the development and implementation of document management policies and procedures.
   3. 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

1. Bachelor’s degree in a relevant field (e.g., Quality Management, life sciences, engineering, or related discipline).
2. Minimum 2–4 years of experience in document control, quality assurance, or a related role in the medical device industry.
3. Familiarity with regulatory standards regarding documentation.