Quality Engineering Manager: Regulatory & CAPA Excellence

Colonial Group; Allen (TX); On-site; USD 150,000 - 190,000; Full time

Job summary

Colonial Group is seeking a seasoned Quality Engineering Director to lead the global Quality Engineering team and ensure compliance with FDA QSR, ISO 13485, and MDSAP requirements across product development and manufacturing.

You will drive CAPA investigations, risk management (FMEA, PFMEA), supplier quality, and continuous improvement initiatives, while partnering with Regulatory, R&D, Operations and Marketing to uphold product quality and regulatory readiness.

Qualifications

• Bachelor-level technical engineering or science degree.
• 8+ years of quality engineering in a highly regulated industry.
• 3+ years managing team members with varied backgrounds and capabilities.
• Excellent knowledge of medical device regulations (FDA 21 CFR Part 820, ISO 13485, EU MDR, MDSAP, ISO 14971), IEC 60601.
• Proven project management skills for multiple projects in dynamic production.
• Solid background in CAPA, RCA, FMEA, Control Plans, statistical techniques, MSA.
• Experience with trending and analytics reporting to drive improvements.
• Strong written and verbal communication; ability to travel up to 25%.

Responsibilities

• Lead Quality Engineering team to support product development, process quality, CAPA, post-market compliance, supplier management, and audits.
• Maintain the Quality Management System and related processes.
• Provide technical leadership to cross-functional teams including Regulatory, R&D, Operations, Engineering, and Marketing.
• Develop and evaluate staff to support design and manufacturing quality.
• Oversee audits and assist Management Representative during regulatory/customer audits.
• Develop and implement efficient quality systems processes.
• Use project management to execute multiple projects with competing resources.
• Establish KPIs and monitor quality metrics to drive improvements.
• Manage CAPA program with investigations and corrective actions to prevent recurrence.
• Apply root cause analysis and statistical methods to manufacturing issues.
• Maintain supplier quality through evaluation, approval, and monitoring; collaborate with supply chain.
• Develop and maintain FMEAs, Control Plans, and SOPs to mitigate risks.
• Support development and validation of new products and production lines.
• Write, review, and approve documents (SOPs, Protocols, Reports, ECOs) impacting product quality.

Skills

Quality engineering

Team management

Regulatory knowledge

CAPA

Root Cause Analysis

FMEA

Control Plans

Statistical methods

Auditing

Education

Bachelor-level degree in Engineering or Science

Job description

Colonial Group is seeking a seasoned Quality Engineering Director to lead the global Quality Engineering team and ensure compliance with FDA QSR, ISO 13485, and MDSAP requirements across product development and manufacturing.

You will drive CAPA investigations, risk management (FMEA, PFMEA), supplier quality, and continuous improvement initiatives, while partnering with Regulatory, R&D, Operations and Marketing to uphold product quality and regulatory readiness.