Senior Quality Engineer — Medical Devices (2nd Shift)

Cirtec Services GmbH; Lowell (MA); On-site; USD 100,000 - 130,000; Full time

Job summary

Cirtec Medical Corporation is seeking a Senior Quality Engineer (2nd shift) to provide hands-on quality engineering support on the manufacturing floor for complex medical device components.

The role leads quality activities across QA/QC, supports transfers, CAPA, IQ/OQ, FMEA, and DOE, and collaborates with cross-functional teams to ensure process stability and regulatory compliance. Candidates should have 5+ years in quality engineering and MES/ERP experience, with strong problem solving.

Qualifications

• Bachelor's degree in a STEM field and 5 years of quality engineering experience.
• Experience in an engineering environment with mechanical, tool design, and manufacturing processes.
• Fluent in Microsoft Office and data analysis; able to present data to management.
• Ability to implement quality programs and drive continuous improvement.
• ISO 13485 and GMP knowledge; experience with MES/ERP systems.

Responsibilities

• Provide quality engineering support for development or sustained manufacturing.
• Lead QA project management for transfers from development to production.
• Own IQ/OQ protocols and verification/validation master plan activities.
• Develop and maintain SOPs and project Quality Plans.
• Perform protocols, analyses, and reports for validations and product development.
• Support CAPA system ownership and supplier quality activities.
• Interact with customers and suppliers on CAPA and investigations.
• Audit support for third party, customer, and internal audits.
• Lead or support FMEA and DOE as applicable.

Skills

Quality engineering

Root cause analysis

Data analysis

MS Office

Problem solving

Quality systems

Continuous improvement

Quality systems ownership

Education

Bachelor's degree in STEM

Tools

MES

ERP

Minitab

Job description

Cirtec Medical Corporation is seeking a Senior Quality Engineer (2nd shift) to provide hands-on quality engineering support on the manufacturing floor for complex medical device components.

The role leads quality activities across QA/QC, supports transfers, CAPA, IQ/OQ, FMEA, and DOE, and collaborates with cross-functional teams to ensure process stability and regulatory compliance. Candidates should have 5+ years in quality engineering and MES/ERP experience, with strong problem solving.