Precision Quality Compliance & Document Control Specialist

ARCH; Escondido (CA); On-site; USD 75,000 - 95,000; Full time

Job summary

ARCH Medical Solutions is seeking a meticulous Quality Compliance & Document Control Specialist to support the QMS across documents, records, and training. You will coordinate audits, CAPA, and regulatory compliance in a precision manufacturing environment serving the medical device industry.

The role requires ISO 13485 experience, document control expertise, and collaboration with cross-functional teams to keep documentation accurate, current, and compliant with customer and regulatory

Qualifications

• Associate degree in a technical, quality, engineering, or related field with 3+ years of relevant experience; or
• Bachelor's degree in Quality, Engineering, Life Sciences, or related discipline preferred; or
• Equivalent combination of education and experience.

Responsibilities

• Maintain and improve the Quality Management System (QMS) per ISO 13485, FDA, and customer requirements.
• Manage QMS documentation, procedures, forms, policies, and records.
• Support internal/external audits and regulatory inspections.
• Coordinate Internal Audit Program and CAPA activities.
• Perform quality data analysis and trend reporting on complaints and metrics.
• Support continuous improvement initiatives and training programs.

Skills

ISO 13485

FDA regulations

Document control

Internal audits

CAPA

ERP systems

Quality data analysis

MS Office

Education

Associate degree in technical/quality/engineering

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

3+ years of relevant experience

Tools

ERP systems

Document management systems

Electronic quality records

Job description

ARCH Medical Solutions is seeking a meticulous Quality Compliance & Document Control Specialist to support the QMS across documents, records, and training. You will coordinate audits, CAPA, and regulatory compliance in a precision manufacturing environment serving the medical device industry.

The role requires ISO 13485 experience, document control expertise, and collaboration with cross-functional teams to keep documentation accurate, current, and compliant with customer and regulatory