Project Coordinator

Operations/Quality           ·        Irvine, CA       ·       Full time

Job Title: Project Coordinator
FLSA: Salaried Exempt
Department: Operations/Quality
Reports To: Sr. Director, Project Management
To apply, e-mail your resume to careers@axonics.com

Job Responsibilities:

This position is part of the Project Management group and will help manage medical device labeling projects in addition to other related projects.

General Description and Duties:

This position will coordinate workflow of various R&D, Operations and Regulatory projects. The job responsibilities include the following:

• Co-ordinate various projects working closely with Regulatory Affairs, R&D, Marketing and Operations teams
• Create project related documentation to meet internal and regulatory agencies requirements
• Co-ordinate with external vendors and internal teams with respect to supply chain issues, parts delivery, and implementation timelines
• Schedule and conduct change reviews
• Participate in risk management activities to address labeling changes
• Review and approve changes including but not limited to drawings, labeling, translations etc.
• Support inventory management
• Ensure compliance with Quality System Regulations
• Establish and maintain team member and project stakeholder relationships, expectations, and communications.
• Manage external vendors and services, as needed for the project.

Position Qualifications:

• Bachelor’s degree in engineering/sciences.
• Working knowledge of FDA medical device quality system regulations
• Proficient in English language.
• Excellent communication, both written and verbal, skills
• Demonstrates ability to work in a highly cross functional and global environment
• Self-motivated with strong focus on details and accuracy.
• Able to work in fast paced environment

Minimum Experience:

• 1 year of project coordinator experience
• 1 years of Medical Device industry experience in R&D, Operations or Regulatory function
• Experience with project management tools such as MS Project
• Experienced in gathering and tracking metrics

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