Principal Product Quality Engineer – Elevate Medical Devices

Cynosure, Inc.; Westford, Northern (MA, KY); Hybrid; USD 90,000 - 130,000; Full time

Job summary

Cynosure, Inc. is a global leader in medical aesthetics based in Westford, MA. We seek a QA professional to strengthen the quality management system, oversee product transfers to contract manufacturers, and drive continuous improvement in product quality and process control.

Responsibilities include root-cause analysis, CAPA, supplier collaboration, and KPI development to ensure compliance with FDA/ISO 13485 requirements. This role offers growth within a high-performance, science-driven culture.

Qualifications

• BS in Electrical, Mechanical or Optical Engineering preferred.
• 5 to 8 years hands-on quality, product development or process development experience.
• Experience in FDA/ISO 13485 regulated medical devices highly preferred.
• ASQ CQE or CQA certification desired.

Responsibilities

• Support local QMS with QE support; interpret quality data and non-conformances.
• Define product quality plans and oversee supplier transfers and validations.
• Manage QC team and coordinate inspection activities to meet production needs.
• Develop KPIs for QC and drive continuous improvements.
• Lead CAPA investigations and risk analyses with cross-functional teams.
• Prepare QA documents and SOPs ensuring regulatory conformance.

Skills

Quality data analysis

Root cause analysis

Problem solving

Communication

Inspection methods

Gage R&R

Process improvement

Cross-functional collaboration

Auditing

Statistical software

Education

BS in Electrical Engineering

BS in Mechanical Engineering

BS in Optical Engineering

Tools

Minitab

Excel

Document control systems

Quality management systems

Job description

Cynosure, Inc. is a global leader in medical aesthetics based in Westford, MA. We seek a QA professional to strengthen the quality management system, oversee product transfers to contract manufacturers, and drive continuous improvement in product quality and process control.

Responsibilities include root-cause analysis, CAPA, supplier collaboration, and KPI development to ensure compliance with FDA/ISO 13485 requirements. This role offers growth within a high-performance, science-driven culture.