Senior Quality Assurance Manager

1 day ago


Concord, California, United States Akesis, Inc. Full time
Akesis, Inc. is seeking a highly skilled RA/QA Senior Specialist to join our team. This role offers an estimated salary of $85,000-$110,000 per year, depending on experience and qualifications.

Job Description:

We are looking for a dedicated professional to manage and maintain our Quality Management System in accordance with MDSAP (ISO13485: 2016) and FDA 21CFR Part 820. This position will also provide technical support on Akesis product components assembly, testing, installation, and servicing.

Key Responsibilities:

  • Manage and maintain the Akesis Quality Management System
  • Provide technical support on Akesis product components assembly, testing, installation, and servicing
  • Familiarize yourself with electrical and mechanical concepts, practices, and procedures

Requirements:

  • 5+ years of work experience in RA/QA for a medical device company
  • Bachelor's degree or equivalent; professional/technical certification desired
  • Experience with DHF, DMR, DHR documentation and Medical Device Files to comply with FDA 21CFR Part 820 QSMR and MDSAP (ISO13485: 2016)

Physical Demands and Work Environment:

The physical demands and work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

This position requires standing, sitting, speaking, and listening for substantial periods. The ability to perform the job safely without endangering oneself or others is essential.

Travel Requirements:

Must be able to travel as needed.



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