Sr. Supplier Quality Engineer

Michigan, Kalamazoo-Battle Creek

Posted: 07/12/2019 Industry: Engineering Job Number: 13287

Our client, a Global Medical Device Manufacture has an immediate opening for a Sr. Supplier Quality Engineer for a 12 Month Contract. Our client offers results-driven people a place where they can make a difference every day! You will also have the opportunity to work with other like-minded, self-directed and detail oriented Top Talents in an extremely collaborative and professional environment.

Position Description (Principle Duties and Responsibilities)

Responsible for quality engineering tasks to support the implementation of EU MDR compliance requirements within a quality system. This will include coordinating with suppliers, reviewing manufacturing documentation, and implementing tasks associated with this regulatory compliance project. This will also include communicating and working with site divisional and operational process owners and team members.

Responsibilities

Develop action plans for EU MDR required items implementation.
Develop close collaboration and communication with site project lead, process owners and team members.
Communicate with site project lead to track and ensure timely progress of project.
Review and disposition changes with process owners which may impact existing and on-going procedures and processes.
Assist cross-functional departments in determining appropriate implementations to support compliance to EU MDR.
Review and provide input on project aspects related to implementation plan.
Prepare, obtain and maintain documentation for Quality Department.
Participate in External Audits and Internal Audits as needed. Ensure Regulatory compliance in area of responsibility to GMP of all medical device regulatory agencies (i.E. FDA, IMB, Notified bodies, etc)

Qualifications

At least 2 years of experience in ISO 13485: 2016 Quality Management System in the Medical Device Industry.
Technical understanding of manufacturing prints and tolerancing
Willing to travel in support of business needs to different geographical locations
Bachelor s degree in engineering field preferred.
Medical device experience is preferred.

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