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Sr Engineer

Job Description

Title             : Sr Engineer
Duration   :  6 months
Location    : Branchburg NJ

Job Description:

  • Consultants will provide hands-on expertise to revise and document the Quality Management System, Clinical, Post-Market Surveillance, and Supplier Management processes as necessary for compliance with the European Union Medical Device Regulations (EU MDR). 
  • In addition, medical device technical files will be reviewed to ensure use of prohibited hazardous substances are in accordance with the limits set forth in the General Product Safety Requirements (Annex I), and records will be created as necessary to fulfill the requirements of the various Annexes.

Job Requirements

Education & Qualification Requirements:
  • Minimum of a Bachelor’s Degree is required, with preference for natural sciences or engineering
  • 5+ years’ experience in Medical Device Quality Systems and/or Quality Assurance
  • Experience with Documentation Control and Change Control
  • First-hand experience with implementation of EU MDR requirements
  • Strong technical writing skills

Job Snapshot

Location US-NJ-Branchburg
Employment Type Full-Time
Pay Type Year
Pay Rate N/A
Store Type Engineering & Aerospace
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Company Overview

Zolon Tech Solutions Inc.

Zolon is committed to our customers. The combination of transparency and continuous communication allows us to form a cohesive and effective bond with our customers. Together, we tailor our consistently proven strategies to provide effective and efficient solutions, implemented with the highest quality through our world class processes. Understanding the customer's business problems and goals resolves into the dependable satisfaction of Zolon's delivery of mutually agreed upon solutions. Our dedication to excellence enables creativity in both services and problem solving, and our ultimate motivation is to perpetually provide the client with quality results. Learn More

Contact Information

US-NJ-Branchburg
Ady James
703-636-3567
Snapshot
Zolon Tech Solutions Inc.
Company:
US-NJ-Branchburg
Location:
Full-Time
Employment Type:
Year
Pay Type:
N/A
Pay Rate:
Engineering & Aerospace
Store Type:

Job Description

Title             : Sr Engineer
Duration   :  6 months
Location    : Branchburg NJ

Job Description:

  • Consultants will provide hands-on expertise to revise and document the Quality Management System, Clinical, Post-Market Surveillance, and Supplier Management processes as necessary for compliance with the European Union Medical Device Regulations (EU MDR). 
  • In addition, medical device technical files will be reviewed to ensure use of prohibited hazardous substances are in accordance with the limits set forth in the General Product Safety Requirements (Annex I), and records will be created as necessary to fulfill the requirements of the various Annexes.

Job Requirements

Education & Qualification Requirements:
  • Minimum of a Bachelor’s Degree is required, with preference for natural sciences or engineering
  • 5+ years’ experience in Medical Device Quality Systems and/or Quality Assurance
  • Experience with Documentation Control and Change Control
  • First-hand experience with implementation of EU MDR requirements
  • Strong technical writing skills
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Sr Engineer Apply now