Document Control Specialist

Job Title: Document Control Specialist

Location: Lenexa, KS

Department: Quality Assurance

Reports to: Director of Quality and Regulatory

Vantage MedTech provides comprehensive design and manufacturing services, supporting the advancement of medical technologies from concept through to product realization. We develop and manufacture new products for the treatment of heart failure, cancer, stroke, Gene Therapy, COPD, TBI, Atrial Fibrillation, Blood Clots, Brain Surgery, and many more! We are searching for top-tier talent to apply their gifts to making life better for hundreds of thousands of patients worldwide. If this is something you aspire to, we would like to talk with you! 

Vantage MedTech is seeking a Document Control Specialist to serve as the cornerstone of Quality Assurance in QMS-related document management, ensuring they meet the highest standards of excellence and ISO 13485 and FDA/regulatory compliance. This role is responsible for maintaining alignment with the Vantage MedTech Quality Management System document control processes, acting as the QA representative on assigned tasks. This individual will enhance the capabilities of the Quality Assurance team by overseeing the maintenance and compliance of the document control processes, while upholding compliance and audit assurance.

• This is not a remote opportunity. This position is based in Lenexa, KS.  Local candidates only. We do not offer relocation assistance.   
  
  

Key Responsibilities:

• Coordinates and provides on-site guidance for the Document Management process to ensure compliance with the Quality Management System (QMS)
• Ensures reviews and approvals of completed documents conform to required processes.
• Executes the routing, reviews, distribution and archiving of new and revised controlled documents. This includes Document Change Orders (DCOs), Engineering Change Orders (ECOs), Corrective Preventive Actions (CAPAs), and other documents or records as assigned
• Works closely with all teams to provide support for the Documentation Management System by collecting, tracking, storing, retrieving, and distributing documents based on the QMS and customer requirements, including scanning/uploading of production DHRs to clients
• Works with department leaders to develop, assign and monitor training
• Tracks status and verifies accurate completion of CAPAs according to QMS requirements.
• Assists with the implementation of engineering change orders including updates to the ERP system, training management and book releases.
• Ensures regular reviews and document audits are completed as required
• Organizes and distributes documents within the organization to ensure the current revision is being used
• Writes and maintains document control procedures and participates in the development/improvement and rollout of document control processes and tools
• Provides support for QMS audits, both internal and external.
• Other duties as assigned by management
  
  

Education and Experience:

• Associate’s degree or equivalent
• Technical proficiency in quality assurance techniques and best practices
• 4 years experience preferred in a regulated QA environment, preferably with FDA QSR, medical devices, related ISO experience, and ERP/data management tools
• Professional appearance and communication skills to facilitate successful interaction with clients and regulatory agencies and effectively interpret and communicate information
• Demonstrated ability to learn quickly and apply new concepts
• Exceptional attention to detail, prioritization, and organization skills
• Flexibility in schedule to meet deadlines and produce results
  
  

Top Benefits/Perks: 

As a team member at Vantage MedTech, you’ll enjoy:  

• Comprehensive benefits package, including health, vision, and dental insurance.
• Paid Time Off.
• Company retirement plan with matching
  
  

Vantage MedTech values a diverse team and is an Equal Opportunity Employer.  We do not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need. All applicants must be authorized for full-time employment in the United States.  For more information, visit www.vantagemedtech.com  

 

No third-party candidates please.