Global Product Quality Engineer - Medical Devices CAPA Lead

Cynosure, LLC.; Westford (MA); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Travel up to 25%

Equal Opportunity Employer

Job summary

Cynosure, LLC. in Massachusetts is seeking a qualified Quality Engineer to oversee product quality, transfer to contract manufacturers, and drive continuous improvement within a FDA/ISO 13485 environment.

You will lead QC activities, support CAPAs, and collaborate with suppliers and manufacturing to ensure compliance and robust quality systems. The role emphasizes interpreting quality data, defining action plans, and maintaining documentation, SOPs, and risk management files.

Qualifications

• Bachelor's degree in Engineering is required.
• 5–8 years of experience in quality, product development, or process development within FDA/ISO 13485 medical devices.
• ASQ CQE or CQA certification is desirable.
• Experience with capital equipment and sterile products is a plus.

Responsibilities

• Support the local QMS with QE support and root cause analysis.
• Coordinate inspections with contract manufacturers and define in-line inspection points.
• Develop and implement KPIs for the QC team and drive improvements.
• Own CAPAs and participate in cross-functional teams to meet quality goals.

Skills

Root cause analysis

QC experience

Communication skills

Statistical analysis

Process improvement

Documentation skills

Education

BS in Engineering

CQE certification

CQA certification

Tools

Minitab

ERP systems

MS Excel

Document control software

Job description

Cynosure, LLC. in Massachusetts is seeking a qualified Quality Engineer to oversee product quality, transfer to contract manufacturers, and drive continuous improvement within a FDA/ISO 13485 environment.

You will lead QC activities, support CAPAs, and collaborate with suppliers and manufacturing to ensure compliance and robust quality systems. The role emphasizes interpreting quality data, defining action plans, and maintaining documentation, SOPs, and risk management files.