Senior Quality Engineer - Medical Devices CAPA Lead

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

Job summary

Colonial Group is seeking a seasoned Quality Engineer to maintain and improve the quality management system across design, development, and manufacturing of components and finished products in Allen, TX. You will lead CAPA initiatives, perform root-cause analyses, and drive corrective actions to eliminate quality problems.

You will audit suppliers, manage supplier metrics, review ECOs and validation reports, and enable strong QMS compliance with FDA/ISO standards.

Qualifications

• Bachelor of Science in a technical field and 5 years in quality engineering in regulated industry.
• Experience in medical device or pharmaceutical manufacturing preferred.
• Strong knowledge of FDA, ISO 13485, ISO 9001, ISO 14971.

Responsibilities

• Maintain and improve the quality management system.
• Lead CAPA activities and root-cause investigations.
• Conduct supplier audits and manage supplier metrics.
• Oversee product testing, validation, and QMS compliance.
• Support internal and external audits; review ECOs and validation reports.
• Mentor QA technicians and production staff.

Skills

Quality engineering

CAPA leadership

Risk assessment

Statistical analysis

Auditing

Supplier quality

QMS

Data analysis

Education

Bachelor of Science in engineering/science

ASQ CQE/CQA

Tools

Minitab

MS Office

Job description

Colonial Group is seeking a seasoned Quality Engineer to maintain and improve the quality management system across design, development, and manufacturing of components and finished products in Allen, TX. You will lead CAPA initiatives, perform root-cause analyses, and drive corrective actions to eliminate quality problems.

You will audit suppliers, manage supplier metrics, review ECOs and validation reports, and enable strong QMS compliance with FDA/ISO standards.