Quality Systems Specialist

6 days ago


Concord, California, United States Akesis, Inc. Full time
Akesis, Inc. invites applications for a RA/QA Senior Specialist position. The successful candidate can expect an annual salary ranging from $80,000 to $105,000. We are particularly interested in candidates with experience in managing quality systems and providing technical support in a medical device setting.

About the Job:

This role involves maintaining our Quality Management System in compliance with MDSAP (ISO13485: 2016) and FDA 21CFR Part 820 regulations. As part of the team, you will also contribute to the development of our products through assembly, testing, installation, and servicing activities.

Main Tasks:

  • Develop and implement strategies for ensuring compliance with regulatory requirements
  • Collaborate with cross-functional teams to design and manufacture high-quality medical devices
  • Stay up-to-date with industry developments and emerging trends in RA/QA and medical devices

Essential Qualifications:

  • At least 5 years of experience in RA/QA roles within a medical device company
  • Bachelor's degree in a relevant field; postgraduate studies or certifications are considered advantageous
  • Proven expertise in creating, managing, and auditing quality documents and records according to FDA guidelines

Workplace Conditions:

This role involves spending significant time working at a computer, participating in meetings, and communicating with colleagues and stakeholders. The individual selected for this position must demonstrate adaptability and flexibility to meet the demands of the role.

Travel Policy:

Occasional business travel is required for training, meetings, and other official purposes.



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