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Associate Regulatory & Quality Engineer

Associate Regulatory & Quality Engineer

 

Regulatory and Quality Solutions LLC (R&Q) is the industry leader in providing regulatory and quality support to medical device companies.  From strategy to tactical implementation, R&Q partners with clients by providing business balanced solutions and hands-on support that enhance the commercialization and post market processes for medical devices.   Balancing the art and science of the regulatory and quality landscape has been the hallmark of R&Q’s mission and cemented it’s essence of the “and means more.” 

 

Being an industry leader in client support is just the beginning for R&Q.  Providing a rewarding place to work is rooted deep in the core values of R&Q.  From an industry leading compensation package to a deeply engrained focus on work life balance, R&Q applies the “and means more” approach to employment.  At R&Q, you are not just another employee, you are a member of the R&Q family. 

 

Position Summary

As a consultant at R&Q, you will have the opportunity to work in many facets in both regulatory and quality, depending on client needs.  We have an immediate openings for an Associate Regulatory & Quality Engineer in NJ to work as Project Employee with R&Q in a contract role.  As an Associate Regulatory & Quality Engineer you will be responsible for providing regulatory and quality solutions on a specific project to assist clients with the introduction, advancement and/or maintenance of their market positions or growth in the market.    

Primary Responsibilities

Under direct supervision, represents R&Q on client projects in area of medical device QA/RA including and provides assistance to more senior engineers in the following areas: 

  • Drafting worldwide regulatory strategies 
  • Developing worldwide regulatory submissions 
  • Providing daily regulatory and quality hands-on support to clients 
  • Conducting quality audits both internal audits and supplier audits 
  • Assisting with design assurance activities; safety risk management, usability, design verification and design validation. 
  • Assisting with process validation and other related quality manufacturing tasks. 
  • Aides in definition of supplier quality specifications, sampling plans, and supplier qualification 
  • Responsible for completing work activities as defined by the project lead on schedule and in accordance with the allotted hours.  

Education and Experience: 

  • Bachelor level degree in engineering or a technical field required; advanced degree preferred. 
  • 0-3 years of working experience.  Medical device experience a plus.   
  • Relevant internship(s) a plus. 
  • Working awareness of FDA Quality System Regulations, EU Medical Devices Directive and International Electric Safety Standards required.  
  • CQA/CQE/Certified Lead Auditor Training preferred.   
  • Advanced computer skills including business applications, statistical data analysis and report writing required.    

Requirements

  • Demonstrates a high performance orientation, a detail orientation, and strong organization skills.   
  • Excellent interpersonal, communication and influencing skills as well as experience working collaboratively with clients, employees and outsiders.   
  • Ability to communicate both orally and in writing with customers at all levels and articulate customer needs accurately.    
  • Willingness to travel extensively - up to 100% - to client locations and to other R&Q regions.   
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