Quality Systems QA Technician – Medical Devices

Socket.dev; California (MO); On-site; USD 70,000 - 95,000; Full time

Job summary

Socket.dev is seeking a Quality Documentation Specialist to ensure ISO 13485 and 21 CFR Part 820/11 compliance. You will establish and maintain the document control system, process changes, and ensure controlled documentation is reviewed and stored properly.

Collaborate with engineering and production to keep documentation up to date, support MRB and training programs, and drive continuous improvement. A Bachelor’s degree and 3+ years in medical device manufacturing are required.

Qualifications

• Bachelor’s degree required; 3+ years in medical device manufacturing.
• Proficient knowledge of ISO13485 and 21 CFR Part 820, Part 11.
• Strong documentation skills and attention to detail.

Responsibilities

• Establish, document, conduct, and maintain the document control system.
• Manage Change Control Board (CCB) and documentation processing.
• Inspect devices and maintain device history records.
• Coordinate with engineering and other departments to ensure timely documentation.
• Provide ongoing communication and status updates to leadership.

Skills

ISO 13485

21 CFR Part 820/11

GD&T blueprint reading

Precision measurement tools

Strong written/verbal communication

Detail oriented

Independent judgment

External stakeholder collaboration

Education

Bachelor’s degree in a related field

3+ years in medical device manufacturing

Tools

MS Office

Quality management software

Job description

Socket.dev is seeking a Quality Documentation Specialist to ensure ISO 13485 and 21 CFR Part 820/11 compliance. You will establish and maintain the document control system, process changes, and ensure controlled documentation is reviewed and stored properly.

Collaborate with engineering and production to keep documentation up to date, support MRB and training programs, and drive continuous improvement. A Bachelor’s degree and 3+ years in medical device manufacturing are required.