Quality Engineer

Highlander Consultants

We are searching for a Quality Assurance Engineer (Junior Grade). You need to have completed your degree, have 5 years of experience, and know how to

Job Description

Quality Assurance Engineer
We are searching for a Quality Assurance Engineer (Junior Grade). You need to have completed your degree, have 5 years of experience, and know how to operate a medical device quality management system. The person hired will be responsible for quality assurance and quality control activities through multiple functional areas in our business. We will teach you how our QMS is established and then expect that you maintain that system in compliance with applicable regulations and standards.

What You Will Be Doing
You will be working as part of an experienced team developing cost effective device solutions for our customers. You will work within our ISO 13485: 2016 compliant quality management system on design, design transfer and production engineering and support activities. You will help to understand and translate customer requirements. Working with a team of other engineers and experienced technicians you will process design concepts and customer input to through design and process validation activities. We are establishing a controlled environment; you will support our operations in that environment.

What You Need for this Position

In General:
You must be able to stand on your own two feet as part of a cross-functional team. If you don’t know how do something; let us know and we will show you how. If you have ideas on how to improve what we do, we will want to hear about it. You have to have a sense of humor and to show respect to everyone in the team.
We do not expect people coming into this position to be experts in all aspects of medical device regulations. However, we work in a regulated industry. You must be willing to learn about and comply with the regulatory requirements of ISO 13485: 2016 and the regulations of the FDA, especially the requirements of:
  • 21 CFR Part 7_Enforcement policy
  • 21 CFR Part 11_Electronic records; electronic signatures
  • 21 CFR Part 800_General.
  • 21 CFR Part 803_Medical device reporting.
  • 21 CFR Part 806_Medical devices; reports of corrections and removals.
  • 21 CFR Part 820_Quality system regulation.
  • 21 CFR Part 830_Unique device identification.
The things we make go into people and help make their lives better. Understanding the significance of what we do is very important.
Required Qualifications:
  • BS/MS in Biomedical, Quality or Mechanical Engineering.
  • Able to demonstrate basic computer proficiency.
  • Microsoft Office Suite (Word especially)
Desired Qualifications:
  • At least 2 years experience working within a quality assurance function for a medical device firm (5 years of experience total).
  • Demonstrated interpersonal skills for the management of staff.
  • Experience in the manufacture of orthopedic implants.
  • Training /understanding of CAD modelling software and the links to CNC lathes and mills.
  • An understanding of statistical process control and the mathematics of process validation.
  • Experience in co-development with external partners / design firms and using engineering best practices desired.
What's In It for You:
*We have a competitive salary base against local pay scales. We offer a team based working environment where output is more valued than what you wear or your ability to be corporately correct.
*Health care insurance is provided.
*This is a start-up. You will learn a lot that is of value throughout your career.
*Job Type: Full-time
* Salary: $65,000.00 to $75,000.00 /year