Document Control Specialist

Position Overview:

The Document Control Specialist is the expert in maintaining control of all Quality Management System documentation and training with respect to medical device regulations and business objectives. All Document Control functions must be compliant with Food and Drug Administration (FDA), International Standards Organization (ISO), Quality Management System Requirements (QMSR), Medical Device Single Audit Program (MDSAP), and other applicable regulatory requirements. This position is responsible for organizing, maintaining, and updating all controlled documents and ensuring training is executed in a timely manner. The Document Control Specialist collaborates with all departments to maintain a compliant program and meet business needs. This position works independently, with minimal supervision, to accomplish daily tasks by efficiently and effectively utilizing the Company's EDMS. The Document Control Specialist will drive continuous improvement within the system and create and maintain metrics regarding document status, priority, change management, training assignment, and training completion. This position will be the Subject Matter Expert (SME) and provide guidance regarding creation, proof-reading, and accuracy of documents. The Document Control Specialist ensures that Design and Development requirements are met within the processes by review and collaboration with stakeholders.

Essential Duties/Responsibilities:

The Document Control Specialist is the EDMS SME, responsible for managing all aspects of the document control processes, including training.

• Document Lifecycle Management: Create, review, revise, and archive Standard Operating Procedures (SOPs), work instructions, marketing documents, technical documents, specifications, and documents of external origin.
• Version Control: Maintain precise revision tracking and document history
• Serves as the Master Control System SME and provides training/guidance to all levels of system end-users
• Implement and streamline document workflows
• Maintains training materials, records, and metrics for the various levels of system users
• Prioritizes Change Control activities by compliance and business requirements
• Drives Change Control to completion using metrics and periodic reporting
• Maintains Change Management and Training processes
• Identifies negative data trends and escalates immediately as necessary
• Manages the release and control of updates to policies, procedures, instructions, etc.
• Manages Quality Records and programs including New Hire Training, activating and deactivating employees in the system, electronic and off-site document retention.
• Communicates effectively with cross-functional and external stakeholders
• Manage vendor and customer change control processes
• Assists with external inspections and audits; preparation and timely support during inspections/audits
• Implements best practice solutions to improve and maintain processes
• Manages Deviation process
• Assumes other responsibilities as assigned by functional manager

Knowledge, Skill, and Abilities:

• Expertise in EDMS systems
• Strong computer knowledge (MS Office)
• Demonstrated initiative and ability to work independently while handling multiple tasks
• Outstanding organizational skills and ability to work systematically and cross-functionally, driving assigned tasks to completion
• Must have strong technical writing and proofreading skills, as well as exemplary attention to detail due to demand for accuracy in controlled documents
• Ability to clearly communicate, both verbal and written
• Good theoretical knowledge with ISO standards and Medical Device Regulations
• Strong focus on internal and external customer service
• Ability to take direction and multi-task in a dynamic environment.
• Ability to work effectively both independently and as part of a team
• High ethics and integrity

Education and Experience:

• Associate Degree and a minimum of 5 years of hands-on work experience in a regulated industry (medical device is strongly preferred) as a Document Control Specialist.

Preferred Skills:

• MasterControl Document System experience
• ISO 13485:2016 Auditor
• MDSAP experience
• Inspection & Audit readiness

Physical Requirements:

• Sitting ~ 75%
• Walking/Bending/Standing/Stooping %: ~25%
• Lifting Requirements <40 lbs

*Applicants must be authorized to work for any employer in the US. We are unable to sponsor or assume responsibility for employment visa/work authorization at this time.

Neuronetics is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy or any other protected characteristic as outlined by federal, state, or local laws. This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. Neuronetics/Greenbrook makes hiring decisions based solely on qualifications, merit, and/or business needs at the time.

*We are committed to providing equal employment opportunities to individuals with disabilities and protected veterans.

Benefits Statement: Selected candidate will be eligible to participate in the Company's employee benefit plans, which currently include: health insurance; dental insurance; vision insurance; optional supplemental medical insurance; health savings and flexible spending accounts; company-paid life insurance and additional voluntary life insurance; company-paid short term disability and long term disability insurance; participation in a 401(k) savings and investment plan with company contribution; and paid time off for non-exempt salaried employees is calculated as .625 per pay period worked for vacation time and .29166 per pay period for personal time. Full-time exempt employees will be eligible for Flex-PTO, which allows time off without accrual. If applicable and required under state law, the successful candidate will also be eligible for paid sick leave. These benefits are subject to plan terms, company policies and are subject to change.

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About Us

Neuronetics, together with Greenbrook Mental Wellness Centers, delivers innovative mental health treatments through FDA-cleared NeuroStar TMS and Spravato therapies. Our mission is to expand access to life-changing care, combining cutting-edge technology, compassionate patient support, and clinical excellence to improve lives every day. Join us in making a meaningful impact in the rapidly growing mental health field.