Job Description

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 Specialist to support the implementation of an electronic Quality Management System (eQMS) 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:

• Develop, implement, and maintain comprehensive record retention systems, policies, and procedures

Implement an electronic file system

Ensure accuracy, quality, and integrity of all company documents

Ensure easy and efficient retrieval of documents

• Responsible for the execution of all Document Change Orders in support of manufacturing, engineering, and other departments, as necessary in accordance with policies and procedures.
• Provide training for all employees on the Document Change Order, training process, and QMS.
• DMR maintenance
• Issue Lab Notebooks.
• Maintain all Training Files for the company.
• Review and update documents for maintenance and quality control, with being audit-ready as the goal.

Preferred Qualifications:

• Excellent interpersonal, verbal, and written communication skills
• Ability to interface with a variety of people and be able to work as part of a team
• Exceptional proofreading and quality control skills
• Experience working in a fast-paced environment as part of a cross-functional team
• Demonstrated track record working with limited direction to produce high-quality work
• Proven ability to provide logical, in-depth analysis of a problem or situation
• Organizational and communication skills enabling accurate and detailed change order processing
• Medical Device experience preferred.
• Familiarity with and MES system
• Label software experience preferred

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.

Job Tags

Similar Jobs