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Quality Engineer - Medical Devices

Location: Grand Rapids, Michigan
Date Posted: 04-05-2018
Quality Engineer, Grand Rapids, MI –

Disher is an engineering services firm based in West Michigan. We are partnered with a manufacturer and distributor of plastic medical devices and products in Grand Rapids, Michigan. We are currently searching for a Quality Engineer to join their small company / culture that is growing quickly. This position is responsible for working with product to identify, analyze, troubleshoot, and resolve non-conformance issues in with various products.
This role is a direct, full-time position, and not with Disher.
 
Qualifications:
 
  • A Bachelor’s Degree in mechanical, industrial, or manufacturing engineering is required.
  • Prior experience in the medical device, pharmaceutical, or medical manufacturing industry is required.
  • One to five years of experience in Quality engineering is preferred.
  • Exposure to the FDA & ISO Standards (13485 & 14971).
  • This is a fast-paced environment, so strong decision-making abilities are important to succeed in this role.
  • Experience with SCARS, Technical Writing, Control Plans, and Supplier control are highly preferred.
  • A strong understanding of mechanical engineering concepts and a skill set in analysis is required, as well as demonstrated technical writing skills. 
  • The individual working in this role will have responsibility for a variety of issues, so time management, prioritization, and organization skills are also important.
 
Essential Duties and Responsibilities:
In this role, the individual will work cross-functionally with all engineering, production, and manufacturing departments, as well as customer service departments to identify, analyze, and resolve various problems with products. It involves the inspection of various products in non-conformance, the coordination of product and materials into quarantine, or for quarantine release, and the root-cause analysis of issues, and the resolution of these issues. This role is responsible for guiding the team and generating technical documentation for communication to internal departments, external clients, and regulating agencies. Responsibilities in various areas and with various teams may bring other responsibilities for this role, as well. This role will require the ability to travel overseas, though only occasionally.
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