Documentation Specialist

Job Title: Documentation Specialist
Location: Moonachie, NJ
Department: Quality Assurance
Reports to: QA Manager/Director
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! 
The Documentation Specialist works closely with all development teams and provides support of the Controlled Documentation Management System in the Medical Device Engineering space. The ideal candidate is a self-starter with a passion for being part of a team supporting the development of medical technologies that improve people’s lives.
** This position is a hybrid opportunity based in Moonachie, NJ. Candidate must either be local or willing to re-locate to the NJ metro area. 
Key Responsibilities:

• Maintain document control and record management systems for the organization. 
• Provide review of design history file for compliance to Vantage process. 
• Responsible for storage, cataloging and retrieval of controlled documents. 
• Ensure internal audits are being performed per schedule and participate in Internal Audits as needed.
• Control and maintain regulatory standards and other external documentation kept in-house as assigned by Department Head of QA, or designee. 
• Maintain, update, and archive the training database. 
• Communicate changes in company policies, work instructions, and procedures. 
• Make recommendations for improving document management system capabilities. 
• Provide general support for internal product development teams. 
• Perform special projects requested from Department Head of QA, or designee. 

Education and Experience:

• High School Diploma. 
• 3 to 8 years’ experience in document control and record management, ideally within the medical device development environment. 
• 3 to 8 years experience working with technical writing. 
• 3 to 8 years experience working within an ISO and FDA compliant Quality Management System. 
• Strong understanding of FDA regulations and related guidance documents. 
• Strong understanding of ISO 13485. 
• Excellent communication skills both written and verbal. Writes concisely and correctly, organizes information clearly.
• Detail oriented, highly organized and process-oriented. 
• Ability to work with a high volume of documents in a fast-paced environment with cross-functional teams.
• Ability to handle multiple requests without affecting quality of output. 
• Ability to perform work electronically by processing information via a computer screen i.e. emails, documents etc., in a timely manner. 
• Ability to interact with team members and staff at every level. 
• Proficient in Microsoft Word, Excel. 

Top Benefits/Perks:  
As a team member at Vantage MedTech, you’ll enjoy:

• Comprehensive benefits package, including health, vision, and dental insurance.
• Generous 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.