QA Team Lead - Medical Devices, ISO 13485 & CAPA Expert

DHD Consulting; Monroe Township (IL); On-site; USD 90,000 - 130,000; Full time

Job summary

DHD Consulting is seeking a Team Manager of Quality Assurance to lead our QA activities in a medical device environment. The role focuses on audit readiness, CAPA management, validation, and document control within ISO 13485 frameworks.

You will coordinate cross-functional teams, oversee internal audits, and drive continuous improvement through KPI monitoring and quality reviews. A Bachelor's degree and 5–7 years in QA are required.

Qualifications

• Bachelor's degree in Biomedical Engineering, Biotechnology, or related life sciences field.
• 5–7 years of QA experience in medical device or pharmaceutical industry, including audit prep and quality system maintenance.
• Experience with ISO 13485 and QMS requirements is preferred.

Responsibilities

• Prepare and maintain the quality system in audit-ready state.
• Lead internal prep for regulatory, customer, and certification audits (ISO 13485/cGMP/MDSAP/IVDR/WHO PQ).
• Respond to auditor inquiries and ensure timely resolution of findings.
• Manage CAPA lifecycle with root-cause analysis, corrective actions, and effectiveness checks.
• Collaborate with cross-functional teams to ensure ongoing compliance and quality improvements.
• Lead validation activities for equipment, processes, and software.
• Oversee document control including SOPs, work instructions, forms, and quality records.

Skills

Audit readiness

CAPA management

Validation

Documentation

Cross-functional teamwork

Attention to detail

Education

Bachelor's degree in Biomedical Engineering, Biotechnology, or related field

Tools

CAPA systems

IQ/OQ/PQ protocols

Job description

DHD Consulting is seeking a Team Manager of Quality Assurance to lead our QA activities in a medical device environment. The role focuses on audit readiness, CAPA management, validation, and document control within ISO 13485 frameworks.

You will coordinate cross-functional teams, oversee internal audits, and drive continuous improvement through KPI monitoring and quality reviews. A Bachelor's degree and 5–7 years in QA are required.