Quality Investigator: CAPA & Root-Cause Analysis

RXinsider LTD.; Irvine (CA); On-site; USD 71,000 - 89,000; Full time

Benefits offered by this job

Healthcare

401(k) plan

Tuition reimbursement

Job summary

B. Braun Medical Inc.

is seeking a Quality Investigator to lead investigations into product, process, supplier, and manufacturing quality issues, partnering with Quality Engineering and Regulatory Affairs to identify root causes and implement CAPAs. Strong analytical skills, experience with quality systems, risk management, and continuous improvement are essential, along with solid data analysis and technical writing abilities.

Qualifications

• Strong understanding of quality management systems and quality processes.
• Knowledge of root cause analysis and problem-solving methodologies.
• Experience with electronic quality management systems (eQMS) preferred.
• Strong technical writing and documentation skills.
• Excellent analytical and organizational abilities.
• Proficiency with Microsoft Office applications, including Excel and Power BI preferred.

Responsibilities

• Lead and document nonconformance, deviation, complaint, CAPA, and quality event investigations.
• Conduct root cause analyses using tools such as 5 Whys, Ishikawa diagrams, Fault Tree Analysis, Pareto, and more.
• Evaluate quality data, manufacturing records, testing results, and process trends to identify causes and factors.
• Ensure investigations are completed accurately, thoroughly, and within established timelines.

Skills

Quality management systems

Root cause analysis

Technical writing

Analytical skills

Cross-functional collaboration

Documentation skills

Education

Bachelor’s degree in Engineering, Quality, Life Sciences, Manufacturing, or a related technical field

Tools

Excel

Power BI

Job description

B. Braun Medical Inc.

is seeking a Quality Investigator to lead investigations into product, process, supplier, and manufacturing quality issues, partnering with Quality Engineering and Regulatory Affairs to identify root causes and implement CAPAs. Strong analytical skills, experience with quality systems, risk management, and continuous improvement are essential, along with solid data analysis and technical writing abilities.