QMS Specialist: CAPA, Audits & Regulatory Compliance

Highridge Medical; Westminster (CO); On-site; USD 90,000 - 120,000; Full time

Job summary

Highridge Medical seeks a Quality Management System Specialist to ensure the organization’s QMS complies with ISO 13485, FDA 21 CFR Part 820, EU MDR, and GMP. The role administers eQMS related to CAPAs and NCs, drives CAPA activities including trending, and supports audits and regulatory inspections to maintain patient safety and product quality.

The position leads CAPA programs, trains staff on CAPA processes, and coordinates health hazard evaluation and field action programs.

Qualifications

• Bachelor’s degree in a technical discipline or equivalent with quality certification preferred.
• Experience with Medical Device or pharmaceutical quality systems and regulatory requirements.

Responsibilities

• Implement and maintain the CAPA program and related software.
• Monitor CAPA metrics, root cause analysis and action plans with timely closure.
• Coordinate CAPA investigations, action plans and verification activities.
• Lead CAPA meetings and maintain CAPA files and training materials.
• Support audits, regulatory inspections and post-market activities.
• Drive health hazard evaluation and field action processes.
• Ensure compliance with ISO 13485, FDA 21 CFR Part 820, EU MDR and GMP.

Skills

CAPA oversight

Regulatory compliance

Quality systems knowledge

Root cause analysis

Communication skills

Time management

Training and mentoring

Problem solving

Education

Bachelor’s degree in a technical discipline

Quality discipline certification (CQE, CQA, etc)

Tools

MS Office (PowerPoint, Excel)

Job description

Highridge Medical seeks a Quality Management System Specialist to ensure the organization’s QMS complies with ISO 13485, FDA 21 CFR Part 820, EU MDR, and GMP. The role administers eQMS related to CAPAs and NCs, drives CAPA activities including trending, and supports audits and regulatory inspections to maintain patient safety and product quality.

The position leads CAPA programs, trains staff on CAPA processes, and coordinates health hazard evaluation and field action programs.