Job Title: 
Quality Assurance Manager

Job Type:
Full time / On-site

Department:
Quality Assurance

Location:
Montvale, NJ

Company Summary

Dynarex is a leading medical supply company providing premium medical products and durable medical equipment at exceptional value — for an unparalleled one-stop shopping experience. Dynarex’s guiding principle “We Care Like Family” exemplifies the outstanding customer service that sets the company apart in the marketplace. Founded in 1967, we have distribution centers in Middletown, NY, Florida, Arkansas, Ohio, and Arizona and distributor partners in all 50 states as well as Canada, the Caribbean Islands, Central America, South America, and the Middle East.

Position Scope

Dynarex Corporation, a leading distributor of medical devices, is seeking a motivated and detail-oriented Quality Assurance Manager to join our Quality Assurance and Regulatory Compliance department. In this critical role, you will act as a key liaison between senior management, customers, internal teams and regulatory bodies, ensuring compliance with FDA and global regulatory standards. This position requires independent judgment, strategic decision-making, the ability to manage complex quality projects, and manage multiple direct reports.

What your impact will look like at Dynarex

Quality Assurance and Vendor Management Activities

· Manage Quality Systems to ensure compliance with FDA and global regulatory requirements.

· Schedule, coordinate, and perform internal audits.

· Act as the primary point of contact for customer complaints, answering quality-related questions via phone or email, and assisting the QA Director in complaint handling.

· Assist Account Managers and Sales Support teams with product-related questions and questionnaires.

· Manage CAPA and SCAR systems, including initiating internal Corrective and Preventive Actions (CAPAs) or Supplier Corrective Action Requests (SCARs) for nonconforming products.

· Identify, review, and disposition non-conforming products, including initiating Requests to Quarantine at all Dynarex warehouses.

· Manage Change Control/Engineering Change Control documentation, including reviewing Engineer Change Requests (ECRs) submitted by the China Office and initiating Change Authorization Notices (CANs) for product, packaging, and labeling changes.

· Coordinate with the China Office and other suppliers to obtain information regarding customer inquiries and product technical specifications.

· Generate Rework Procedures for products requiring rework at any Dynarex warehouse.

· Review vendor specifications and create Dynarex technical spec sheets for new products in the New Product Development (NPD) phase.

· Perform sample evaluations and final inspections for new products prior to launch.

· Perform Quality Assurance departmental and cross-functional training.

· Establish best practices for quality assurance and document control.

· Serve as the subject matter expert on regulatory requirements for the above-mentioned electronic systems.

 

Project Management

· Lead and manage eQMS projects, ensuring timely implementation.

· Monitor changes in regulatory requirements and recommend updates to company policies or procedures.

· Coordinate external audits and inspections, preparing and presenting compliance documentation to auditors.

 

Database Oversight and Documentation Control

· Oversee the development, implementation, and maintenance of databases for quality and regulatory documents, ensuring accurate and secure data management.

 

Training and Communication

· Design and deliver training programs for the Quality Assurance Department and cross-functional teams.

· Act as the primary resource for regulatory inquiries, audits, and investigations.

· Provide manufacturing documentation upon request to customers or regulatory bodies.

 

Research and Analysis

· Conduct in-depth research on customer complaints and non-conforming products, providing recommendations for resolution and compliance.

· Analyze quality and compliance metrics, preparing reports for senior management.

 

You will love this job if you have:

To excel in this role, you will need:

· A bachelor’s degree in a related field (e.g., Regulatory Affairs, Quality Management, Life Sciences, or related discipline).

· 7+ years of experience in regulatory compliance, quality assurance, or a similar role within the medical device or healthcare industry.

· Comprehensive knowledge of FDA regulations and ISO 13485:2016 requirements.

· Strong project management skills with the ability to handle multiple priorities effectively.

· Advanced proficiency in Microsoft Office Suite and database management systems.

· Excellent written and verbal communication skills, with the ability to present complex information clearly.

· Proven ability to exercise discretion and independent judgment in regulatory matters.

 

We care like family, come join a world-class progressive organization with a sustainable mission.

For candidates meeting all the requirements, the expected base salary is $75,000 to $85,000 per year. The range provided is the salary that Dynarex Corporation in good faith believes at the time of this posting that it is willing to pay for the advertised position. Exact compensation will be determined based on individual candidate qualifications and experience. Our benefits package includes coverage options for medical, dental, vision, prescription drugs, health savings accounts, 401K with a match, EAP, Basic Term Life insurance, paid time off, holidays, and various opportunities for professional development.

Disclaimers:

· This job description is not designed to cover or contain a comprehensive listing of all activities, duties or responsibilities required by an employee.

· Dynarex Corporation does not accept resumes from search firms for this position. Regardless of past practice, all resumes submitted by search firms are to be deemed the sole property of Dynarex Corporation, and no fee will be paid in the event the candidate is hired by Dynarex Corporation because of the referral.

 

Equal Opportunity Statement

Dynarex Corporation is committed to equal employment opportunities and providing reasonable accommodation to applicants with physical and/or mental disabilities. We value and encourage diversity and solicit applications from all qualified applicants without regard to race, color, gender, sex, age, religion, creed, national origin, ancestry, citizenship, marital status, sexual orientation, physical or mental disability, medical condition, veteran status, gender identity, genetic information, or any other characteristic protected by federal, state, or local law.

Application Process: Interested candidates should submit their resume and a cover letter detailing their relevant experience and why they are a good fit for this role. Applications can be sent via our job posting Indeed-link or submitted through our website at www.dynarex.com

Apply:
Submit your resume to hr-jobs@Dynarex.com and please include the Job Title in the subject line.