Senior Quality Engineer

Creative Solutions Services, LLC; Arden Hills (MN); On-site; USD 90,000 - 120,000; Full time

Job summary

Creative Solutions Services, LLC seeks a Senior Quality Engineer – Quality Systems to lead quality system activities in a regulated medical device environment. You will drive CAPA, RCA, nonconformances, and risk management with a focus on data-driven decisions and process validation.

The role requires hands-on experience with CAPA, RCA, nonconformance investigations, and ISO 13485/FDA 21 CFR 820 knowledge, along with statistical methods and data trending.

Qualifications

• Bachelor's degree in engineering, science, statistics, or related field.
• 4–7+ years of Quality Engineering / Quality Systems / CAPA / Nonconformance / Applied Statistics experience.
• Strong medical device industry experience preferred.

Responsibilities

• Lead CAPA investigations and verify effectiveness.
• Investigate nonconformances and drive corrective actions.
• Perform RCA using quality tools and methodologies.
• Develop and maintain Quality Plans for products and processes.
• Determine sampling sizes and statistical methods for validation.
• Develop QC sampling plans using risk-based approaches.
• Analyze and trend quality data to identify recurring issues.
• Apply SPC, control charts, CUSUM, hypothesis testing and related methods.
• Support process capability and performance analysis.
• Conduct quality and process risk assessments per ISO 14971.
• Support change control and assess validation impacts.
• Review quality data to identify adverse trends and systemic issues.
• Assist audits and inspections with quality documentation.
• Ensure compliance with FDA 21 CFR 820, ISO 13485, ISO 14971.

Skills

CAPA investigations

Root Cause Analysis

Nonconformance investigations

Statistical analysis

Process validation

Quality data trending

ISO 13485 knowledge

FDA 21 CFR 820

Statistical software

Excel proficiency

Communication skills

Problem solving

Education

Bachelor's degree in engineering, science, statistics, or related field

Tools

Minitab

JMP

Excel

Job description

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