Our client is currently seeking candidates for the position of Quality Engineer in Atlanta, Georgia. The successful applicant will be reviewing, updating, and/or generating Quality Management System (QMS) Procedures in an ISO 13485 design and manufacturing facility environment. The process of updating and generating such documents will require contributions from all relevant stakeholders and their buy-in with the finalized processes and supporting documents. At the discretion of management, the incumbent may be given other assignments requiring a less comprehensive skill set.
Responsibilities of the Quality Engineer:
- Obtaining a working overview of our products and our organization, Familiarizing oneself with our existing QMS,Interviewing QMS stakeholders to understand the functional interrelationships and actions dictated in the QMS, and Performing a “desk audit” of our system against ISO 13485 using the knowledge gained about the company
- Reporting out findings to Quality management
- Developing and receiving approval of concepts to remedy the desk audit findings as reported to Quality management
- Collaboratively developing and/or revising procedures to implement the agreed upon remedial concepts
- Projects will be driven by revisions to existing product lines and will include design control documentation, risk management documentation, and new equipment validation.
- Collaborating with a network of contract medical device manufacturers
- Facilitate a gated development process and associated decision-making and detailed documentation
- write and implement comprehensive verification and validation plans
Requirements of the Quality Engineer:
- 5+ years engineering and manufacturing experience in medical device, specifically experience in FDA CFR 820 and ISO 13485 regulated environments
- Experience working within regulations of ISO13485, FDA, and CE compliance. Ideally, recent training in ISO13485-2016
- 3rd Party Manufacturing: Experience – collaborating with a network of contract medical device manufacturers
- Experience working with design control documentation and risk management documentation
- Engineering Degree required