Medical Device QA & Documentation Specialist

Precision One Medical; Oceanside (CA); On-site; USD 85,000 - 115,000; Full time

Job summary

Precision One Medical in Oceanside, CA seeks a quality/document control professional with 3+ years in medical device manufacturing. You will manage the QMS documentation, ensure regulatory compliance, and support change control and training programs.

Responsibilities include maintaining device history records, coordinating with engineering, and driving continuous improvement in document control processes to sustain high-quality manufacturing operations.

Qualifications

• Bachelor's degree required.
• 3+ years in a medical device manufacturing environment.
• Proficient with ISO13485, 21 CFR Part 820/11, and ISO 14971.

Responsibilities

• Adhere to ISO13485 and company QMS requirements.
• Establish and maintain document control system with approvals, changes, storage, and retrieval.
• Manage Change Control Board (CCB) activities and documentation.
• Prepare, process, and distribute quality manufacturing documentation.
• Inspect device components per procedures and maintain history records.
• Coordinate with engineering and other departments to meet production schedules with complete documentation.
• Manage company training program and ensure regulatory requirements are met.
• Identify continuous improvement opportunities in document control processes.
• Provide status updates to senior management and interface with stakeholders.

Skills

Detailed orientation

Independent judgment

Verbal communication

Written communication

Project collaboration

Computer literacy

Education

Bachelor's degree

Tools

Micrometers

Calipers

Gauges

Optical comparators

Job description

Precision One Medical in Oceanside, CA seeks a quality/document control professional with 3+ years in medical device manufacturing. You will manage the QMS documentation, ensure regulatory compliance, and support change control and training programs.

Responsibilities include maintaining device history records, coordinating with engineering, and driving continuous improvement in document control processes to sustain high-quality manufacturing operations.