ISO 13485 Quality & Document Control Specialist

Arch-Medical-Solutions; Escondido (CA); On-site; USD 75,000 - 95,000; Full time

Job summary

ARCH Medical Solutions is seeking a detail-oriented Quality Compliance & Document Control Specialist to support the maintenance, effectiveness, and compliance of our Quality Management System (QMS).

This role combines responsibility for document control, training administration, audit readiness, regulatory compliance, quality records management, and continuous improvement initiatives within a precision machining environment serving the medical device industry.

Qualifications

• Associate degree with 3+ years in quality/document control or regulatory compliance.
• Bachelor’s degree in Quality, Engineering, Life Sciences preferred.
• Experience in Quality Systems and ISO 13485 in a regulated environment.
• Experience with medical device manufacturing and ERP systems helpful.
• Strong written communication and attention to detail.

Responsibilities

• Maintain and improve the QMS per ISO 13485 and FDA requirements.
• Manage documentation, revision status, forms, policies, and records.
• Support internal audits, external audits, and CAPA activities.
• Coordinate training programs and maintain training records.
• Support regulatory inspections and supplier documentation control.
• Analyze quality data and drive continuous improvement initiatives.
• Assist with ECO processing and change controls as needed.
• Interface with cross-functional teams on quality documentation matters.

Skills

Document control

QMS

Internal audits

CAPA

Regulatory compliance

Quality data analysis

Cross-functional collaboration

Education

Associate degree in technical/quality

Bachelor's degree preferred in Quality/Engineering/Life Sciences

Equivalent education/experience

Tools

ERP systems

Document management systems

Electronic Quality Records

Job description

ARCH Medical Solutions is seeking a detail-oriented Quality Compliance & Document Control Specialist to support the maintenance, effectiveness, and compliance of our Quality Management System (QMS).

This role combines responsibility for document control, training administration, audit readiness, regulatory compliance, quality records management, and continuous improvement initiatives within a precision machining environment serving the medical device industry.