Quality Assurance Engineer

company banner
Judge Group, Inc.
Quality, Engineer, FDA, ISO, Engineers, Mechanical, Engineering, Biomedical, PC, Microsoft Word, Microsoft Excel, PowerPoint
Full Time

Job Description

Location: Plymouth, MN
Description: Our client is currently seeking a Quality Assurance Engineer for a 12 month + contract.

Medical device experience is needed.

Description/Comment: Provide support and direction for the implementation of EU MDR requirements including product gap assessments.

Will work within the new product development team, with responsibilities including, but not limited to the following:

Guide NPI teams through our internal quality system to ensure products are developed in compliance to those procedures as well as the requirements of the FDA, ISO, and other regulatory bodies. Mentors, provides oversight and approval of NC & CAPA, activist and high level expert in problem solving and root causing activities.

Review and evaluate project documentation for compliance as well as sound technical competence to ensure we are delivering robust products/processes.

Involved in developing, modifying, and executing design controls per company guidelines and procedures.

Provide input throughout the new product development process from a quality perspective

Lead risk management for project including risk analysis and development of sound mitigation strategies

Lead efforts for usability and human factors engineering

Collaborate with Design Engineers to develop robust verification test strategies to ensure safe, reliable products are implemented.

Support process and product validation programs for new product development

Educate NPI team on the use of risk management tools, statistical methods, design and process control activities, and sound verification and validation test planning to help drive quality upfront in new product development.

May perform supplier development activities surrounding PPAP

Develop and create procedures for incoming, in-process and final inspection of components and finished goods

May have involvement in continuous improvement projects for the organization

Knows and applies fundamental and some advanced concepts, practices and procedures of practical field of specialization.

Additional Job Details:

Bachelor's Degree in Mechanical Engineering, Biomedical Engineering or equivalent discipline is required.

A minimum of 2-3 years experience in a Technical Engineering or Quality Engineering position within an R&D or manufacturing environment

A minimum of three years' experience as an AQE or Design Quality Engineer preferred

Previous experience in a regulated environment preferred

ASQ CQE, CRE, CSSBB or equivalent course work / experience desirable

Knowledge or certification in GD&T preferred

Proficient understanding of Med Device manufacturing processes

Familiarity with ISO 13485, GDP, GMP, MDR.

Excellent communication skills and attention to detail

Has a strong understanding of engineering and quality practices & methods

High level of PC skills. Must be proficient with Microsoft Word, Microsoft Excel, PowerPoint and One Note.

Self-starter with demonstrated efficient work methods, analytical & problem solving skills and ability to handle multiple tasks in a fast paced environment.

Working knowledge/experience of statistical techniques

Knowledge in reliability engineering practices preferred

Highly developed problem solving and strong analytical skills

Builds strong relationships by fostering open communications, respect and trust. Strong team player and acts with a customer service/stakeholder focused approach

Is diplomatic, tactful and leverages excellent interpersonal skills to help achieve outcomes.

Manages change well and adopts a continuous improvement orientation to the role

Ability to be the voice of Quality when dealing cross functionally. Will take the lead in discussions / meetings to ensure the correct outcome.


This job and many more are available through The Judge Group. Find us on the web at www.judge.com

Company Information

The Judge Group, celebrating its 50th anniversary, is a leading professional services firm specializing in talent, technology, and learning solutions. We consult, staff, train, and solve. Through our work we make people and organizations better. Our services are successfully delivered through a network of more than 30 offices in the United States, Canada, and India. The Judge Group serves more than 50 of the Fortune 100 and is responsible for over 9,000 professionals on assignment annually across a wide range of industries.

Dice Id : cxjudgpa
Position Id : 706939
Originally Posted : 2 months ago

Similar Positions at Judge Group, Inc.

Quality Engineer
  • Mendota, MN
  • 3 days ago
Sr. Quality Assurance Engineer
  • Franklin, TN
  • 3 days ago
Sr. Quality Assurance Engineer
  • Mahwah, NJ
  • 3 days ago
Supply Quality Engineer
  • Lincolnshire, IL
  • 3 days ago
Quality Assurance - Basic
  • Chicago, IL
  • 3 days ago
Supplier Quality Engineer
  • Portage, MI
  • 3 days ago
Sr. Quality Engineer
  • Las Vegas, NV
  • 3 days ago
Quality Assurance
  • Tampa, FL
  • 3 days ago