Quality Engineer II - QA, CAPA & Regulatory Compliance

Katalyst-Healthcares-; Plymouth (MN); On-site; USD 70,000 - 95,000; Full time

Job summary

Katalyst-Healthcares- is seeking a Quality Engineer II to ensure products, processes, and quality records meet established standards and regulatory requirements. The role involves investigations, CAPA, complaint handling, and root-cause analyses across cross-functional teams.

The ideal candidate brings 2–5 years in quality assurance or engineering, strong analytical skills, and experience with QMS systems in a regulated environment.

Qualifications

• Bachelor's degree in engineering or technical field.
• 2–5 years of technical experience.
• Experience in Quality Assurance or Quality Engineering.
• Knowledge of quality tools and root-cause analysis.
• Experience with nonconformance investigations, CAPA, or complaints.
• Strong data analysis, reporting, and communication skills.
• Ability to manage multiple priorities in a dynamic environment.

Responsibilities

• Ensure FDA, GMP, ISO standards, and company quality requirements.
• Maintain and improve the Quality Management System (QMS).
• Identify quality risks and ensure regulatory compliance.
• Conduct nonconformance investigations, CAPA, and product complaints.
• Perform root-cause analysis and recommend corrective actions.
• Develop and maintain QA procedures, forms, and documentation.
• Analyze quality data, track trends, and identify manufacturing-related issues.
• Prepare investigation reports and communicate findings to stakeholders.
• Lead meetings and communicate quality system updates and improvements.
• Collaborate with cross-functional teams to resolve quality issues.
• Support continuous improvement and maintain accurate quality records.

Skills

Root-cause analysis

Data analysis

Quality assurance

CAPA

Complaint management

Report writing

Communication skills

Multitasking

Problem solving

Cross-functional teamwork

Education

Bachelor's degree in Engineering

Tools

QMS software

Statistical software

Job description

Katalyst-Healthcares- is seeking a Quality Engineer II to ensure products, processes, and quality records meet established standards and regulatory requirements. The role involves investigations, CAPA, complaint handling, and root-cause analyses across cross-functional teams.

The ideal candidate brings 2–5 years in quality assurance or engineering, strong analytical skills, and experience with QMS systems in a regulated environment.