Quality Assurance Manager

Reports to: Sr. Director Regulatory & Quality

 

Job Location: Redwood City, CA

Job Summary:

  • Develop and maintain Exo’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

 

Education/Experience Requirements:

 

  • 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

CONNECT

3600 Bridge Parkway 

Suite 102

Redwood City, CA 94065

​​

exoinfo@exo.inc

  • LinkedIn - White Circle
  • Twitter
  • Facebook
  • Instagram
  • Spotify