Job summary:
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.
Roles & 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, ISO13485, ISO 14971, and applicable company procedures.
Required Qualifications:
Bachelor's degree in engineering, Science, Statistics, or related technical field
4–7+ 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
