Quality Engineer - CAPA & Continuous Improvement (Austin)

Flex; Austin (TX); On-site; USD 90,000 - 135,000; Full time

Job summary

Flex is seeking a Quality Engineer to join the Austin, TX team. The role focuses on CAPA ownership, root-cause investigations, and maintaining QMS compliance across regulatory requirements. You will collaborate with Manufacturing, Regulatory Affairs, and Operations to drive quality improvements.

Responsibilities include leading CAPA activities, performing data-driven analyses, and developing corrective actions to prevent recurrence, while ensuring accuracy and traceability of quality data.

Qualifications

• Bachelor’s degree in engineering or related field is required.
• Typically requires 6 years of experience in engineering in high-technology electronics or related fields.
• Experience with CAPA, Nonconformance Management, Complaint Handling, Change Control, and Risk Management processes.
• Strong knowledge of QMS and regulatory requirements (FDA 21 CFR Part 820, ISO 13485, ISO 14971).
• Experience with electronic quality management systems (eQMS) and quality data analysis tools.

Responsibilities

• Lead CAPA activities from initiation through closure with compliance to internal procedures and regulatory standards.
• Conduct root-cause analyses using structured methods (5 Whys, Fishbone, FTA).
• Evaluate quality data, manufacturing metrics and customer feedback to identify systemic issues.
• Develop and approve correction and preventive action plans to prevent recurrence.
• Coordinate cross-functional teams to drive timely CAPA execution.
• Assist with audits and regulatory inspections.

Skills

CAPA management

Root cause analysis

Quality data analysis

Cross-functional collaboration

Regulatory compliance

Education

Bachelor's degree in engineering or related field

Tools

eQMS software

MS Excel

5 Whys & Fishbone tools

Job description

Flex is seeking a Quality Engineer to join the Austin, TX team. The role focuses on CAPA ownership, root-cause investigations, and maintaining QMS compliance across regulatory requirements. You will collaborate with Manufacturing, Regulatory Affairs, and Operations to drive quality improvements.

Responsibilities include leading CAPA activities, performing data-driven analyses, and developing corrective actions to prevent recurrence, while ensuring accuracy and traceability of quality data.