What are the responsibilities and job description for the Document Control Coordinator (Medical Devices Industry) @ Andover, MA position at NextPhase.ai?
WHO WE ARE
Nextphase.ai is a Data Management solution provider focused on Data Operations services for enterprise data in the cloud. We are leading the innovation agenda with our clients by delivering a portfolio of services to help them improve data quality and manage data governance for their cloud data. NextPhase.ai data management services are tailored to achieve our client’s business outcomes thus enabling our clients to focus on monetizing their data while we handle data operations. Nextphase.ai provides you with a dynamic and fun work environment and encourages you to use creative thinking to solve client challenges.
Position Overview:
We are seeking a detail-oriented Document Control Coordinator to support the implementation of an electronic Quality Management System (eQMS) and assist with Document Control Department support in a fast-paced medical device environment. This role is critical to ensuring compliance with regulatory requirements (FDA, ISO 13485, EU MDR) and maintaining robust documentation practices throughout the organization.
Responsibilities:
This position is responsible for, but not limited to, the following:
- Assist in the deployment and configuration of the eQMS platform
- Manage document lifecycle activities: creation, review, approval, distribution, revision, and archival
- Ensure documents meet internal formatting standards and regulatory requirements
- Maintain accurate records of controlled documents and change history
- Monitor compliance with document control policies and escalate discrepancies
- Collaborate with Quality, Regulatory, R&D, and Operations teams to streamline documentation processes
- Internal reporting for various company system metrics and goal
- Scanning of Quality Documentation
- Help to maintain training records within the document management system
Management Responsibilities:
This position manages the following positions on a daily basis.
- This position will not have management responsibilities.
Physical Attributes:
- Office environment
- Must be able to lift up to 30lbs
Minimum Qualifications:
- Minimum of 3 - 5 years’ experience in the Documentation Control role.
- High School Diploma
- Familiarity with eQMS platforms and document management systems
- Working knowledge of FDA 21 CFR Part 820, Part 11, ISO 13485, and EU MDR Requirements
- Strong attention to detail and organizational skills
- Excellent communication and interpersonal abilities
- Proficiency in Microsoft Office Suite and PDF editing tools
Preferred Qualifications:
- Medical Device experience preferred.
- Experience with eQMS implementation or migration projects
- Some knowledge of validation and change control processes
- Ability to manage multiple priorities in a regulated environment
Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship or employment visas currently.
NextPhase.ai is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.
