Job Responsibilities (including but not limited to):

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• Develop and maintain Exo Imaging’s Quality System in compliance with all applicable regulatory requirements (ex. 21 CFR 820, ISO 13485, CMDR etc)

• Writes and/or implements changes to controlled documents (e.g., SOPs, specifications, methods, etc.) as needed to ensure defined quality objectives are met

• Oversees Document Control processes, including regulatory standards updates and validation of electronic QMS systems

• Serves as a lead/coordinator of investigations and corrective and preventive actions (CAPA)

• Oversees the Complaint Reporting and Post Market Surveillance Systems

• Coordinates Internal Audits and ensures implementation of audit feed-back

• Leads Medical Device Regulations (EU) implementation efforts

• Oversees Supplier Management process, from initial sourcing through development and commercial phases as well as sustaining supplier activities. May conduct supplier audits as required

• Oversees employee training program

• Monitor, track/trend all KPI and periodically provide a summary report to senior management, including participation in Management Review meetings

• Represent the company as a Quality Assurance subject matter expert during internal and external regulatory inspections

• Work effectively and influence multiple functions (R&D, Operations, Program Management, Regulatory, Supply Chain etc.) to ensure Quality expectations are met

• Provide coaching to Exo personnel on Quality Systems requirements and process improvement methodologies

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Education/Experience Requirements:

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• Minimum of a Bachelor of Science Degree in Engineering or similar scientific field with at least 8 years of experience in the medical device industry

• At least 3 years of direct managerial responsibility leading aspects of Quality System for Medical Devices

• Exceptional working knowledge and understanding of Quality System regulations (21CFR 820 and ISO 13485), Risk Assessment (ISO 14971), requirements related to software (IEC 62304)

• Excellent verbal, written, communication and proficient computer skills, specifically with statistical software and Microsoft Office Suite including Word, Excel, PowerPoint

• Certification by ASQ (Certified Quality Auditor, Certified Quality Engineer, and Certified Quality Manager) or other industry-recognized professional organizations is preferred

• Superior time management skills, ability to work on several projects simultaneously and excellent communication skills required

• Available to travel up to 10% of the time

 

If interested, please send resume and cover letter to atiwari@exo.inc