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Quality Engineer

Quality Engineer

Northeast Biomedical Inc. is seeking a Quality Engineer with 2+ years of experience in medical devices, quality systems, and product development to join our fun but hard-working team in Tyngsboro, MA. In this role, you will become an integral part of our development team, managing, and contributing to the design and development of medical devices and equipment. This position offers growth and flexibility. 

To excel within this environment, the right candidate will not only provide expertise when needed but also interact with our exemplary team to ensure the highest level of customer service.  

Responsibilities: 

  • Maintain and improve our internal ISO 13485:2016 system under the guidance of senior staff and consultants.  
  • Support management and task level deliverables within our customers ISO & FDA Quality Management Systems 
  • Support from the design process from initial concept through market launch, ensuring on-time submission of deliverables. 
  • Work with teams to create requirements documentation, test plans, routers, design review documentation, and other project specific quality documentation.  
  • Participate in client interactions with clear communication as it relates to quality documentation, design reviews, and deadlines. 
  • Work independently and as part of a team involving members at all levels of our organization, as well as clients. 
  • Remain apprised of the progress of certain projects, paying particular attention to any developing problems, and participate in major problem resolutions. 
  • Communicate to other teammates and management any significant deviations from quality plans. 
  • Coordinate internal team staffing and quality requirements for projects. 

Qualifications:  

  • Strong written and oral communication with the ability to think creatively within a team environment. 
  • A willingness to learn as well as a positive attitude. (We like to laugh!). 
  • Adept at operating within, and contributing to, an ISO 13485 quality environment. 
  • Strong desire to succeed in all that you do, particularly in an entrepreneurial organization. 
  • BS/MS in engineering from an accredited engineering program or equivalent.  
  • 2-5 years of quality engineering experience from both a system level and product launch perspective.  
  • 2-5 years of medical device development experience. 
  • U.S. employment eligible. 

Please, no Recruitment Agency calls or Staffing Agency inquiries.  
We thank you for not calling our company and saving needed time on both parties’ behalf. All information will be retrieved via email. We will contact those qualified for the position posted. We appreciate your cooperation. 

This is an Equal Employment Opportunity. 

Please be aware no compensation is provided for relocation. 

Please send a resume to careers@northeastbiomed.com


About Northeast Biomedical 

Northeast Biomedical was founded a decade ago in Tyngsboro, MA. We are an ISO 13485:2016 medical device product development and contract manufacturing company that develops a variety of products for our customers. We have in-depth experience in catheters, disposable devices, sensors, optical systems, laser products, instrumentation, test fixtures, robotics, and automation equipment.   

The team at NEB is a small, tight-knit group that accepts challenges head-on and works collaboratively to bring new medical devices to market. We work hard, play hard, and truly enjoy what we do. 

Our website has more information about us: www.northeastbiomed.com 

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