As QA Specialist, you will be responsible for overseeing and managing the Ganymed Robotics document control and training systems, including creating and processing change orders for updating all company documents such as standard operating procedures, work instructions, and Quality Management System training to remain in compliance with ISO 13485 and 21 CFR 820. You will be a key member in the development and implementation of the company’s new eQMS system. If you have at least 3 years’ experience in class II/III Medical Device Quality Documentation you should check us out! 

Responsibilities 

• Assist in the management of the Document Control and Training processes. 

• Create and review document Change Orders(CO’s) for revision controlled documents to ensure compliance to all Ganymed Robotics’ policies and procedures. 

• Ensure Change Order training and implementation plans are complete, and notification of closed Change Orders communicated in a timely manner. 

• Maintenance of Quality records including audits, management reviews, training, master and obsolete documents, etc. 

• Support associated Quality improvements systems, including Corrective and Preventive Action (CAPA) and Nonconforming Materials.  

• Creation and maintenance of Standard Operating Procedures (SOP), Work Instructions, and Forms relating to document control, Quality System Training, and other areas as required by Quality and Regulatory. 

• Manage companywide training matrices and training plans to track employee requirements with general and competency training programs, in compliance with ISO and FDA requirements. 

• Assist in the coordination of group and self-study training and document notifications as required. 

• Other duties as assigned.

Requirements 

• Self-starter with the ability to contribute to the efforts of a startup medical device company with minimal supervision. 

• Strong proficiency and organizational skills using Microsoft Office Suite, Adobe, SolidWorks, and Product Lifecycle Management (PLM) systems. 

• In-depth knowledge of Document Control Change Systems. 

• Strong knowledge of 21CFR part 820 and ISO 13485 regulations for Procedure writing and editing. 

• Experience preparing presentations for company group training in multiple areas including, Quality Systems training and Document Control. 

• Coordination of companywide Quality System training program for compliance with FDA and ISO requirements. 

• Experience / background in Document Control  

• Strong French and English language fluency / skills 

• Experience with Product Lifecycle Management / Electronic Document Management software program(s). Experience working with Greenlight Guru a plus.  

• Experience working in a highly regulated industry (particularly medical devices) a plus 

• Must be a team player 

• Must be able to adapt to rapidly changing work environment 

• Strong interpersonal skills to collaborate with individuals across all levels of the company 

Experience 

• Bachelor’s degree in Science, Engineering, or Drafting 

• 3 Years’ experience with implementation of Documentation Control within the medical device industry  

• Familiarity with FDA and ISO requirements 

• Working knowledge of Device Master Records, Design History File, PLM system