Quality Engineer - Medical Devices, CAPA & Compliance

MiRus®; Marietta (GA); On-site; CAD 98,000 - 133,000; Full time

Job summary

MiRus is seeking a Quality Engineer to apply Quality Engineering and QA methods for new product development and line support. You will ensure compliance with federal, industry, and corporate procedures during receipt, storage, manufacturing, and distribution of products.

Location: Marietta, Georgia. Employee Type: Full-time. Responsibilities include CAPA, audit readiness, SOP creation and deviation management, with a focus on data‑driven quality improvements and regulatory adherence.

Qualifications

• Bachelor’s degree in engineering, science or technical field.
• 2+ years of quality, engineering, operations or program management in medical industry.
• Knowledge of 21 CFR Part 820, ISO 13485, EU Medical Device Directive and international standards.
• Knowledge of ISO 14971 risk management and hazard analysis techniques.
• Authorized to work in the United States and able to pass pre‑employment checks.

Responsibilities

• Directly support CAPA, training, audit preparedness and quality system efficiencies.
• Support compliance in all phases of design, development, manufacture and release.
• Author, review and approve SOPs, protocols, test reports and other records for accuracy.
• Maintain deviations, non-conformances, CAPAs, customer complaints and change controls.
• Create or refine test strategies, plans and metrics with guidance.
• Perform internal or supplier quality system audits as assigned.

Skills

Quality Engineering

CAPA

Regulatory compliance

Documentation

Audits

Data analysis

Education

Bachelor's degree in engineering or science

Job description

MiRus is seeking a Quality Engineer to apply Quality Engineering and QA methods for new product development and line support. You will ensure compliance with federal, industry, and corporate procedures during receipt, storage, manufacturing, and distribution of products.

Location: Marietta, Georgia. Employee Type: Full-time. Responsibilities include CAPA, audit readiness, SOP creation and deviation management, with a focus on data‑driven quality improvements and regulatory adherence.