We are looking for a Document Control Specialist to join our team and experience what being "The Best Virtual Care Solution" means.
Some of the perks that our employees enjoy include:
- Growth possibilities
- Competitive Health & Welfare Benefits
- Company paid Basic Life insurance: $50,000 for each employee
- Company paid Long-Term Disability benefits
- 401k plan with company match
- Employee Appreciation Days
- Employee Wellness Events
- Competitive pay
Other benefit offering includes:
- Dental insurance
- Disability insurance
- Employee assistance program
- Flexible spending account
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Vision insurance
Job Summary:
The Document Control Specialist position coordinates, collects, maintains, and distributes all documents required by the Quality Management System (QMS) used to define product configuration and control manufacturing processes that ensure conformance to customer, regulatory, and international standard requirements. Maintains the electronic and physical document directories of all documents to be retained in the document control center. Manages the operation of the document control center including storage, retrieval, revisions, tracking and reporting on document review progress.
Duties & Responsibilities:
- Collect and maintain files of the latest revision level documentation necessary to meet requirements of company Quality Management System (QMS)
- Timely distribution of latest revision level documentation to all appropriate users and ensure that obsolete documentation is removed from distribution
- Maintain document control database of all filed documentation and records to ensure fast retrieval of documents
- Execute Document / Record Control Management procedures.
- Manage archival activities for controlled documents and validation of files to meet requirements of 21 CFR part 820 and ISO 13485 by ensuring standard practices and procedures are followed when analyzing data and content
- Provide support during audits by 3rd parties
- Assist with documentation of non-conformance and corrective action events
- Assist with creating quality documents such as Work Instructions, Standard Operating Procedures, and Design control documents in a controlled environment
- Assist with processing new and versioning document changes requests, administrative changes, document retirement, and deviations utilizing change control systems, and procedures
- Knowledge of all types of documentation necessary for ISO 13485 compliance systems including: Engineering Prints, Document Change Requests, Engineering Change Requests, Health & Safety Documentation, Corrective Actions, and Preventive Actions.
- Perform clerical typing duties to generate documents.
- Performs other related duties as assigned.
Qualifications:
- High school diploma or general education degree (GED).
- Other: One-year related work experience and/or training.
Skills & Competencies:
- Demonstrated understanding of ISO 13485 and FDA 21 CFR Part 820 compliant document systems
- ISO 13485 medical device quality system environments including: Design, manufacture, post market, and improvement activities.
- Proficiency in Adobe Acrobat, and Microsoft Office programs (Word, Excel, PowerPoint, ect.)
- Synthesizes complex or diverse information; Collects, researches, and evaluates data; Excellent attention to detail.
- Exercises excessive care in the consideration and treatment of details.
- Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.
- Displays willingness to make decisions; Exhibits sound and accurate judgment; Supports and explains reasoning for decisions; Includes appropriate people in decision-making process; Makes timely decisions.
- Focuses on solving conflict, not blaming; Maintains confidentiality; Listens to others without interrupting; Keeps emotions under control; Remains open to others' ideas and tries new things.
Physical Demands & Work Environment:
- Ability to work at least 40 hours per week.
- Ability to utilize keyboard, mouse and computer for up to 7 hours per day.
- Ability to utilize telephone for approximately 1 hour per day.
- Ability to lift and/or move at least 25 pounds.
- Ability to perform simple grasping, including handwriting, paper manipulation, sorting, folding, etc. periodically throughout the entire workday.
- Continually remain in a stationary position throughout day.
- Occasionally move about inside and outside the premises.
- Occasionally work near moving mechanical parts.
- Occasionally travel using a motor vehicle or utilize air travel.
GlobalMed is an equal opportunity employer. We are committed to providing a workplace that is free from discrimination of any kind and to promoting an environment that fosters inclusion, diversity, and mutual respect among our employees. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected status under applicable law. GlobalMed is dedicated to ensuring the fulfillment of this policy with respect to hiring, placement, promotion, transfer, demotion, layoff, termination, recruitment, compensation, and any other terms and conditions of employment. We actively seek diversity in our workplace and encourage candidates from all backgrounds to apply. Reasonable accommodations will be made for qualified individuals with disabilities.
