NextPhase.ai
Document Control Specialist (Medical Devices Industry) @ Andover, MA
NextPhase.ai, Andover, Massachusetts, us, 05544
Document Control Specialist (Medical Devices Industry) – Andover, MA
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
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. Execute 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 process and QMS. Maintain DMR documentation. Maintain all Training Files for the company. Review and update documents for maintenance and quality control, with audit‑ready as the goal. Preferred Qualifications
Excellent interpersonal, verbal, and written communication skills. Ability to interface with a variety of people and 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 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.
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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
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. Execute 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 process and QMS. Maintain DMR documentation. Maintain all Training Files for the company. Review and update documents for maintenance and quality control, with audit‑ready as the goal. Preferred Qualifications
Excellent interpersonal, verbal, and written communication skills. Ability to interface with a variety of people and 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 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.
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