Lead Quality Engineer - Medical Devices CAPA

Colonial Group; Allen (TX); On-site; USD 90,000 - 130,000; Full time

Job summary

Colonial Group is seeking an experienced Quality Engineer to maintain and enhance the quality management system across design, development, and manufacturing of medical devices.

The role emphasizes CAPA leadership, root cause analyses, and risk assessments for new and existing products, including supplier quality oversight and audits. You will engage with cross-functional teams to ensure compliance and drive continuous improvement.

Qualifications

• BS in a technical field required; minimum 10 years in a quality engineering role in regulated industry such as medical device or pharma.
• Minimum 5 years’ experience in the medical device manufacturing industry preferred.
• Expertise with FDA QSR, ISO13485, MDD, ISO 9001, and ISO 14971; IEC 60601 experience.

Responsibilities

• Maintain and continually improve the quality management system (QMS) and related procedures.
• Lead CAPA and risk assessment activities for new and existing products.
• Support supplier quality through audits, metrics, and corrective actions.
• Oversee internal and external audits and verify corrective action effectiveness.
• Generate, review, and approve ECOs and validation reports.
• Provide technical guidance to QA technicians and production staff.
• Collaborate with engineering project teams to improve product quality and process capability.

Skills

Quality engineering

Regulatory compliance

Root cause analysis

CAPA management

Statistical analysis

Project management

Auditing

Education

Bachelor's degree in engineering or technical field

Tools

Minitab

MS Office

Job description

Colonial Group is seeking an experienced Quality Engineer to maintain and enhance the quality management system across design, development, and manufacturing of medical devices.

The role emphasizes CAPA leadership, root cause analyses, and risk assessments for new and existing products, including supplier quality oversight and audits. You will engage with cross-functional teams to ensure compliance and drive continuous improvement.