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QMS Regulatory Affairs Specialist

Operations | San Jose, CA | Full Time

Job Description

About Us:

PreXion, Inc. develops, markets, and supports systems for dental imaging applications. Its mission is to develop and deploy innovative imaging products that deliver high performance and superior image quality based on unique image processing technologies. Our headquarters are near the San Jose Airport with close access to light rail. 

About the position:

PreXion is seeking a QMS Regulatory Affairs Specialist responsible for evaluating and improving the Quality Management System by employing best practices to ensure compliance to applicable Medical regulations/standards. This is a flexible, remote position with occasional travel the San Jose office. This position will require someone to assume a broad set of responsibilities. This is a mid-level Quality Control position reporting to the VP of Operations and communicating with Quality Control Manager in Japan. The candidate must be willing to shift or take on new challenges as they arise in this small company.

Responsibilities:

  • This person will be the main point of contact for PreXion Inc’s Quality Management System. 
  • This person should have knowledge of MDSAP, FDA and ISO 13485 protocols. 
  • The daily tasks will include making sure procedures are followed to the QM and keeping records on file for audits.  
  • Participate in MDSAP preparation, assessment, and audit management activities.
  • File and maintain FDA2579 Forms for Assembly of Xray Devices
  • Implement tactical plans to meet Company and Corporate objectives, and supporting the development and implementation of policies to ensure compliance with applicable US Federal and local regulations
  • Maintains up-to-date knowledge and ensures compliance with local, state, and federal regulations and standards including compliance with Food & Drug Administration (FDA)

Qualifications:

  • A minimum of a Bachelor’s Degree is required. 
  • 2 plus years’ experience working in quality control
  • Demonstrated working knowledge of Risk Management practices, Corrective and Preventative Actions and regulatory requirements such as FDA QSR’s, ISO 13485, MDSAP and other applicable standards and regulations.
  •  A solid knowledge of Microsoft Office products including Word, Excel, PowerPoint and Outlook is required
  •  Excellent qualitative and quantitative analytical skills and the ability to think strategically
  •  Excellent communication skills is a MUST, both verbal and written
  •  Experience demonstrating a high degree of self-motivation and attention to detail in a position with little or no supervision

In addition to a dynamic place to work and competitive salary, our San Jose building has a Fitness Center for employees to access.

PreXion, Inc. is an equal opportunity employer.