Medical Device Quality Documents Coordinator

Precision One Medical, Inc.; Oceanside (CA); On-site; USD 65,000 - 85,000; Full time

Job summary

Precision One Medical, Inc. seeks an experienced Document Control Specialist to uphold the Quality Management System and manage the company document control process.

This role ensures controlled documentation is reviewed, approved, and properly stored across digital and physical records. The ideal candidate will have 3+ years in a medical device setting, knowledge of ISO standards, and strong communication skills to coordinate with engineering and production teams.

Qualifications

• Proficient with ISO13485 and 21 CFR Part 820/11
• Solid understanding of QSR ISO 14971
• Basic blueprint reading (GD&T)
• Basic measurement instrument skills (micrometers, calipers)
• Ability to adapt to changes and meet deadlines
• Strong written and verbal communication
• Detail-oriented and independent decision-maker
• Collaborates effectively with cross-functional teams

Responsibilities

• Maintain and improve the document control system per procedures
• Manage Change Control Board (CCB) and document processing tasks
• Prepare, process, and distribute quality manufacturing documents
• Oversee document storage and retrieval for hardcopy/electronic records
• Review and maintain device history records and inspection plans
• Support nonconforming materials (MRB) activities
• Coordinate with engineering to meet production schedules with complete documentation
• Manage company training program to meet regulatory requirements
• Identify continuous improvement opportunities for document control processes

Skills

ISO13485

21 CFR Part 820

Part 11

Quality system regulations

GD&T

Measuring instruments

Strong communication

Independent judgment

Education

Bachelor's degree or equivalent

Tools

Microsoft Office

Job description

Precision One Medical, Inc. seeks an experienced Document Control Specialist to uphold the Quality Management System and manage the company document control process.

This role ensures controlled documentation is reviewed, approved, and properly stored across digital and physical records. The ideal candidate will have 3+ years in a medical device setting, knowledge of ISO standards, and strong communication skills to coordinate with engineering and production teams.