Job description
Description
The Document Control Specialist is primarily responsible for managing and maintaining the records required to support the Quality Management System, including product and product development, and business activities. The Document Control Specialist will also support the Quality and Regulatory team by performing general quality system activities.
Requirements
Essential Duties and Responsibilities
Lead the maintenance and continuous improvement of the Document Management System (DMS)
Work with team members to ensure technical documentation and filings are complete and reflect current practice
Ensure maintenance of technical and business related documentation, including routing, approval, and storage of electronic records.
Enforce compliance to applicable standards and escalate to appropriate authorities if needed.
Support regulatory, customer, and internal audits.
Assist in general tasks to support the maintenance and improvement of the Quality Management System
PLEASE NOTE: This is not an exhaustive list of all duties, responsibilities and requirements of the position described above. Other functions may be assigned and management retains the right to add or change duties at any time.
Minimum Qualifications, Education and Experience
Associate’s degree in relevant field (or equivalent experience)
2 - 4 years working in a regulated industry (FDA and Software as a Medical Device preferred) as a document control specialist
Experience creating and maintaining both paper and electronic records
Basic knowledge and understanding of Quality System Regulations, including but not limited, to 21 CFR 11, 21 CFR 820, and ISO 13485.
Experience interacting with Regulatory Authorities
Excellent written and oral communication skills, including English
Quality Standards
Communicates, cooperates, and consistently functions professionally and harmoniously with all levels of supervision, co-workers, patients, visitors, and vendors.
Demonstrates initiative, personal awareness, professionalism and integrity, and exercises confidentiality in all areas of performance.
Follows all local, state and federal laws concerning employment to include but not limited to: I-9, Harassment, EEOC, Civil rights and ADA.
Follows OSHA regulations, RadNet and site protocols, policies and procedures.
Follows HIPAA, compliance, privacy, safety and confidentiality standards at all times.
Practices universal safety precautions.
Promotes good public relations on the phone and in person.
Adapts and is willing to learn new tasks, methods, and systems.
Reports to work regularly as scheduled; consistently punctual with respect to working hours, meal and rest breaks, and maintains satisfactory personal attendance in accordance with RadNet guidelines.
Consistently adheres to the time management policies and procedures.
Completes job responsibilities in a quality and timely manner.
Physical Demands
This position often requires sitting, standing, walking, bending, twisting, reaching with hands and arms, using hands and fingers, handling, or feeling, speaking, listening, and high-level cognitive thinking. Also, must be able to lift up to 10 pounds occasionally. The position requires the ability to travel (~10% of time), drive a vehicle, and utilize other forms of transportation.
Working Environment
Remote setting.
ACCOMMODATIONS
Reasonable accommodations may be made to enable people with disabilities to perform the essential functions of the job.
