Senior Quality Engineer

About the role

We are seeking a Senior Quality Engineer Quality Systems to support and drive quality system activities within a regulated medical device manufacturing environment. The ideal candidate will have strong hands-on experience in CAPA, nonconformance investigations, root cause analysis, risk management, statistical analysis, process validation, and quality data trending.

Responsibilities

• Lead and support CAPA investigations, including problem definition, root cause analysis, corrective and preventive actions, implementation, and effectiveness verification.
• Investigate product and process nonconformances, identify root causes, and support appropriate product disposition and corrective actions.
• Perform structured Root Cause Analysis (RCA) using appropriate problem-solving methodologies and quality tools.
• Develop, review, and maintain Quality Plans for products, processes, and manufacturing activities.
• Determine appropriate sample sizes, sampling strategies, and statistical methods for process validation, verification, and validation activities.
• Develop and review QC sampling plans using risk-based approaches and applicable standards such as ANSI/ASQ Z1.4.
• Analyze and trend process, product, inspection, complaint, and quality system data to identify recurring issues and opportunities for improvement.
• Apply statistical techniques including SPC, control charts, CUSUM, hypothesis testing, Fisher's exact test, and other appropriate statistical methods.
• Support process capability and performance analysis and provide recommendations based on statistical findings.
• Perform and document quality and process risk assessments in accordance with ISO 14971 and company procedures.
• Support change control activities, including assessment of quality and validation impacts associated with proposed changes.
• Review quality data and metrics to identify adverse trends, process variation, and potential systemic issues.
• Support internal, external, and regulatory audits and inspections, including preparation and presentation of quality system documentation.
• Ensure quality activities and documentation comply with FDA 21 CFR 820, ISO 13485, ISO 14971, and applicable company procedures.

Requirements

• Bachelor's degree in engineering, Science, Statistics, or related technical field
• 47+ years of Quality Engineering / Quality Systems / CAPA / Nonconformance / Applied Statistics experience
• Strong medical device industry experience preferred
• Hands-on experience with CAPA, RCA, nonconformance investigations & effectiveness verification
• Knowledge of ISO 13485, FDA 21 CFR 820 & ISO 14971
• Experience with statistical sampling, sample size determination, ANSI/ASQ Z1.4, SPC, control charts & trending
• Proficiency with statistical software and Microsoft Excel
• Strong analytical, documentation, communication, and problem-solving skills