Document Control manages and tracks controlled documents against standards and country specific regulations for the purpose of ensuring our company remains compliant. The Document Control position is responsible for organizing and maintaining all controlled documents throughout the document lifecycle, assisting in document review for projects, and conducting various regulatory projects as needed. This position is a champion for regulatory compliance in our business. Role should be meticulously detailed and organized, reliable and committed, and a proven self-starter who requires minimal oversight. In depth knowledge and comprehension of regulatory standards is essential with ability to work in a fast-paced and deadline driven environment. The goal is to ensure that our Quality Management System and processes are compliant and efficient for the purposes of protecting our business regarding controlled documentation, certifications, and country specific registrations which are needed to grow our business and achieve long-term success. Candidate must have knowledge of and ability to comprehend ISO 13485 and FDA requirements. Responsibilities include, but are not limited to:
o Good documentation practices and documenting activities with regard to all records, procedures, forms, templates, and work instructions
o Maintain a clean, organized, safe work environment o Perform other quality or business-related duties as needed
o Provide Good Documentation Practices, document control, and quality training pertaining to document control and regulatory issues, as needed.
o Contribute on cross-functional teams. Willing to learn new areas of expertise.
o Create procedures, work instructions, and forms as needed for more efficient execution of activities o Facilitate understanding of the quality system when working with other areas of the company
o Support maintenance of the quality system maintaining vigilance and reporting non-compliances and nonconformances as required
o Focus on areas for improvement, continuously pursue operational excellence
o Assess daily, weekly, monthly, quarterly throughput so that resource allocation needs may be assessed and reassigned as needed
Primary; IMSXpress Documentation Module Administration:
o Learn about IMSXpress and more efficient ways to store, retrieve, and use system for US Endodontics needs.
o Coordinate and maintain controlled documentation both physically and electronically according to approved procedures.
o Assist with file migration to storage and electronically, as applicable.
o Ensure all documents are current, properly identified, and maintained per applicable standards and regulations.
o Prepare reports on timeliness of documentation updates results.
Primary; Document ownership:
o Labels o DFUs
o Lot Cards
o Procedures, work instructions, and forms regarding document control and record retention.
o Create templates for all document types to ensure a streamlined documentation system. May include but not be limited to font type and size to be used, rules for formatting and bulletizing documents, and table formatting rules.
Primary; Document Change Administration:
o Process document change request workflows: Author, revise, develop, approve, and archive controlled documentation such as forms and procedures, as appropriate.
o Coordinate with owners to ensure that documents are updated in a timely manner
o Ensure that all associated records are pulled for review by respective owners when a process or procedure are changed
o Review all documentation updates to ensure formatting, grammar, and punctuation are correct.
o Increase efficiency regarding document change requests.
o Aid in understanding of quality and regulatory requirements to help document owners update procedures
Secondary; Internal Auditor:
o Perform internal audits, as needed.
o Maintain certification o Write internal audit reports and follow procedure.
Secondary; Regulatory Affairs:
o Aid in gathering necessary documentation for new product or new market registration
o Attend meetings with marketing and sales as needed to understand market strategy
o Develop subject matter expertise in regulatory.
Back-up; Complaint Investigator:
o Administrate complaint process.
o Communicate with distributors to ensure that complaints are initiated and RMAs are given in a timely manner
o Follow procedure and provide weekly reviews to applicable distributors as required
o Initiate complaints and CAPAs as needed per procedure
Back-up; Admin to Supplier Control, Calibration, and Complaint Module in IMSXpress
Back-up; Nonconformance/CAPA initiator/investigator o Initiate Nonconformance/CAPA in IMSXpress and on QF-83-01-1 for nonconforming incoming, in-process, and finished products, as applicable o Examine, analyze, and investigate damaged product for input into the Nonconformance/CAPA process o Aid in recording and monitoring manufacturing processes with regard to Nonconformance/CAPA and quality issues o Support and participate in Material Review Board for NC decisions
Key Skill Requirements:
Professional oral and written communication skills
Ability to analyze and reconcile moderately complex issues
Attention to detail and exceptional organizational skills
Time Management and communication skills
Ability to work with minimal supervision
Minimum of 3 years working knowledge of Microsoft Word and Excel
Ability to work within and lead a team
Flexible to work overtime as business requires
Prior clerical experience with document control support Preferred Qualifications:
Preferred A.S./A.A. Degree in Quality, Technology, or Business
At least 2 years experience in a medical device manufacturing environment
Experience with ISO 13485 and FDA regulations for medical devices
Experience with IMSXpress
Experience with ISO13485 and FDA-regulated environment preferred
Ability to work with a team
Must be flexible to work overtime as business requires
US Endodontics is an Equal Employment Opportunity Employer and does not discriminate against applicants or employees on the basis of race, color, religion, creed, national origin, ancestry, disability that can be reasonably accommodated without undue hardship, sex, sexual orientation, gender identity, age, citizenship, marital or veteran status, or any other legally protected status.
Job Type: Full-time
Salary: $17.00 to $25.00 /hour