Document Control Specialist

Neuronetics, Inc. • Malvern, PA

4h • Onsite

About The Position

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.

Requirements

• 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
• 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
• 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.
• 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.

Nice To Haves

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

Responsibilities

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

Benefits

• 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
• 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.
• Flex-PTO for full-time exempt employees
• paid sick leave (if applicable and required under state law)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree