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