huMannity Medtec · 1 day ago
Document Control Specialist
Santa Clarita, CA
Full-time
Onsite
Mid Level
$35/hr - $45/hr
3+ years exphuMannity Medtec is a company at the forefront of medical technology innovation, seeking a Document Control Specialist to enhance their Quality Assurance team. The role involves managing controlled documents and ensuring compliance with quality standards while supporting documentation activities across the organization.
Health CareHospitalMedical
Responsibilities
Reviews documents for completeness and identifies issues such as typos, grammatical errors, incomplete data, formatting discrepancies etc. and edits documents on behalf of the originator to correct the issues identified
Resolves document processing issues
Ensure documents are processed quickly and correctly
Processes Document Change requests in a timely manner
Creates Engineering Change Orders (ECO)
Collaborate with cross-functional departments to ensure timely completion of change requests and change orders (ECR/ECO’s)
Follow up with document originators if documents are not uploaded in a timely manner after an ECO is created
Reviews and maintains document logs on a regular basis to ensure data integrity
Establish and Run weekly CCB meetings
Process document periodic reviews timely and efficiently
Compiles data and generates reports, updates ECO KPI
Ensures training is assigned to appropriate personnel and completed in a timely manner
Maintains training matrix
Actively send reminders out to trainees if training is pending
Enter parts, fixtures and assemblies into the inventory control system in a timely manner, soon after the parts are released
Update and maintain SOPs pertaining to document control and training
Subject Matter Expert for document control and training
Qualification
Required
3+ years of experience in the medical device industry or related area
Must be very detail-oriented, and work well with Engineering, Manufacturing, Quality and R&D personnel
Advanced computer skills and experience working with Microsoft Office Professional including Word, Excel, PowerPoint, Vizio, and database programs
Advanced document editing and formatting experience
Demonstrated knowledge and basic proficiency with electronic document management systems
Experience with ERP systems
Ability to examine documents such as drawings, procedures, and specifications to verify that Document Control requirements have been met
Ability to assist personnel with creating documentation in accordance with Standard Operating Procedures and Word templates
Ability to work independently on multiple assignments with competing priorities
Willingness to assist in performing Quality Assurance tasks
Experience with ISO 13485 or ISO 9001 document control requirements
Benefits
9/80 schedule with every other Friday off
26 long weekends a year
Company
huMannity Medtec
huMannity Medtec provides medical conditions.
51-200 employees
Funding
Current Stage
Growth StageLeadership Team
Anthony Ng
Director of Electrical Engineering
Company data provided by crunchbase