Quality Engineer

3 weeks ago

Rochester, United States Next Phase Medical Devices, an Arterex Company Full time

Job DescriptionJob Description

We are seeking a highly skilled Quality Engineer to join our team.

About Arterex

Arterex is a multi-capability medical device contract manufacturing platform resulting from the combination of Kabo, Formula Plastics, Luc & Bel, ModenPlast, and NextPhase. The company serves a wide range of customers, from leading global medical and healthcare OEMs to smaller regional specialty customers primarily in the United States and Europe. Arterex has a global manufacturing footprint with 7 state-of-the-art facilities across the US, Mexico, Italy, and Egypt. Additional information is available at www.arterexmedical.com.

The Quality Engineer position is based in our Rochester, NH NextPhase facility and reports directly to the Director of Quality Assurance.  The Quality Engineer is responsible for managing all technical activities for internal and external customer projects involving complex disposable medical products.  The Quality Engineer works as part of a Value Stream Team to ensure product quality and adherence to the Quality Management System is maintained. 

Other responsibilities include:

  •   Coordinate and perform Corrective Action and Preventive Action activities as required.
  •   Provide product specification and task specific instructions for use by assembly and quality personnel, including the specification of inspection or measuring equipment to be utilized.
  •   Investigate, document and communicate customer complaints.
  •   Monitor and evaluate supply quality, recommending improvements as needed. 
  •   Control, document, evaluate and disposition nonconforming materials.
  •   Partner with manufacturing to ensure defect, scrap and rework prevention.

Required Skills, Knowledge and Experience:

  •   Familiarity and prior experience working in a regulated environment, i.e., medical device, aerospace, automotive or other      similar industry.
  •   Experience working with Federal Drug Administration (FDA) Quality System regulations.
  •   Understanding of ETO and Gamma Sterilization.
  •   Previous work experience in a contract manufacturing environment preferred.
  •   Proficient in Microsoft Office Suite
  •   Bachelor of Science degree in engineering, biology or other related science discipline preferred.
  •   3+ years Quality or other regulatory working experience. 

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