Quality Engineer II - Med Device QA & Process Improvement

Cirtec Services GmbH; Brooklyn Park (MN); On-site; USD 80,000 - 95,000; Full time

Benefits offered by this job

Healthcare & Wellness

Training & Career Development

401(k) with company match

PTO

Job summary

Cirtec Medical Corporation is seeking a Quality Engineer to monitor and audit manufactured goods in a medical device setting. You will identify defects, determine causes, and implement corrective actions while collaborating with customers and suppliers on engineering projects.

Responsibilities include quality engineering support across development and manufacturing, CAPA ownership, validation protocol development, and process improvements to drive compliance and product quality.

Qualifications

• Bachelor's degree in a STEM field is required.
• Minimum of 2 years' engineering experience in a related field.
• Experience with medical devices or regulated environments is preferred.
• Strong data analysis and quality improvement mindset.
• Proficiency with Microsoft Office applications.

Responsibilities

• Provide Quality Engineering support for development or manufacturing.
• Lead CAPA investigations and issue resolution with root-cause analysis.
• Develop and manage validation plans and SOPs.
• Support product transfers from validation to production.
• Coordinate with customers and suppliers on quality-related matters.
• Implement continuous improvement initiatives for processes.
• Review changes to procedures to ensure quality system compliance.

Skills

Quality Engineering

CAPA Management

DOE & Stats

Validation

Process Improvement

Data Analysis

MS Office

English Proficiency

Education

Bachelor's degree in STEM field

Tools

Microsoft Word

Excel

PowerPoint

Access

Job description

Cirtec Medical Corporation is seeking a Quality Engineer to monitor and audit manufactured goods in a medical device setting. You will identify defects, determine causes, and implement corrective actions while collaborating with customers and suppliers on engineering projects.

Responsibilities include quality engineering support across development and manufacturing, CAPA ownership, validation protocol development, and process improvements to drive compliance and product quality.