Quality Engineer I - Medical Devices (Growth & Validation)

Cirtec Medical; Lowell (MA); On-site; USD 80,000 - 85,000; Full time

Benefits offered by this job

Training & career development

Healthcare, dental, vision

Wellness programs

Paid time off

401(k) retirement with company match

Job summary

Cirtec Medical in Lowell, MA seeks a Quality Engineer to monitor and audit the quality of manufactured medical devices. You will identify root causes, develop corrective actions, and collaborate with customers and suppliers on engineering projects.

The role requires a BS in engineering, fluency in English, and strong data analysis and communication skills. You will work within a comprehensive quality system, drive continuous improvement, and support audits and supplier performance activities.

Qualifications

• Bachelor's of Science degree in engineering.
• Proficient with data analysis in MS Office.
• Excellent English reading/writing and verbal communication.
• Strong organizational and management skills.

Responsibilities

• Provide Quality Engineering support for engineering project development or sustained manufacturing.
• Provide Quality Project Management support for product transfers from development to validation.
• Validation System Owner responsible for VMP development and validation determinations.
• Develop and maintain Validation SOPs and project Quality Plans.
• Develop protocols, perform statistical analyses, and write reports for validations and DOEs.
• Support IQ/OQ protocols to ensure compliance with the Quality System.

Skills

English proficiency

Data analysis (MS Office)

Verbal communication

Organizational skills

Education

Bachelor's of Science in engineering

Tools

MS Office

Job description

Cirtec Medical in Lowell, MA seeks a Quality Engineer to monitor and audit the quality of manufactured medical devices. You will identify root causes, develop corrective actions, and collaborate with customers and suppliers on engineering projects.

The role requires a BS in engineering, fluency in English, and strong data analysis and communication skills. You will work within a comprehensive quality system, drive continuous improvement, and support audits and supplier performance activities.