Senior Quality Engineer – CAPA, RCA & Medical Device

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

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.