Careers
Position: Document Control Specialist
Department: Quality
POSITION SUMMARY
This Document Control Specialist is the Company’s expert in the control and maintenance of all Quality Management System (QMS) documentation. The position is responsible for the accurate preparation, release, change control, and distribution of all QMS including, but not limited to procedures, work instructions, tech files, labeling, IFUs, and training records. Assists Quality Management in maintaining a QMS that is in compliance with all medical device and governing body regulations.
PRINCIPAL RESPONSIBILITIES
- Maintains the integrity of the document control system. Authorized to place, replace, revise and/or obsolete quality documents. Has the responsibility to confirm the accuracy of Work Instructions, Standard Operating Procedures, Quality Records, forms and other documents against specifications.
- Maintains the documentation files in compliance with ISO 13485, FDA 21 CFR 820, EU MDR/2017 and other regulatory requirements.
- Responsible for control and maintenance of all formal Quality Management System files to include company Device Master Records, Device History Records, Design History Files and CE Technical Files. Responds promptly, whenever possible, to requests for information specific to these QMS documents.
- Produces, reviews, controls and confirms accuracy of product labeling that meet regulatory and customer requirements, in cooperation with engineering and business development.
- Interacts effectively with regulatory or governing bodies including FDA and EU Representatives, as required.
- Controls and maintains consistent product identification (e.g.- product name, product IDs, etc.) across various quality processes.
- Assists in preparation of data for Management Review.
- Assists Quality Management with all internal and external audits.
- Other duties as required
EDUCATION/EXPERIENCE REQUIREMENTS
- High School Diploma or equivalent, college courses or associate’s degree preferred.
- 2-3 years of document control experience within an ISO-compliant quality system.
- 2-3 years of hands-on regulatory/quality experience in a medical equipment/device company.
SPECIALIZED SKILLS & OTHER REQUIREMENTS
- Extreme attention to detail in document content, naming conventions and organization.
- Strong writing skills in a professional environment.
- Professional discipline, sense of urgency, understanding of team dynamics, and working cooperatively with other departments.
- Knowledge of ISO-certified Quality Systems. ISO 13485, FDA 21CFR 820, and EU MDR/2017 strongly preferred.
- Must have multitasking abilities, be self-motivated and solid project management skills.
- Proficiency with technical subject matter, including writing procedures and work instructions.
- Working knowledge of desktop computer software, database software, scanning software and email applications.
- Ability to operate in an online ERP and QMS environment.
- Proficient in the use of MS Excel and MS Word programs
- Strong professional communication skills, including composing concise and effective internal and external e-mails.
TRAVEL REQUIREMENTS: None
WORKING ENVIRONMENT: Office