Senior Quality Engineer - Medical Devices, Onsite

Spectra Medical Devices, LLC; Wilmington (MA); On-site; USD 115,000 - 130,000; Full time

Job summary

Spectra Medical Devices, LLC in Wilmington, Massachusetts, is seeking a Senior Quality Engineer to lead quality programs in a medical device environment. You will manage supplier quality agreements, support customer complaints, and drive CAPA, NCR, and internal audit activities to ensure regulatory compliance.

The role requires a Bachelor’s degree and 5+ years in quality engineering, knowledge of ISO 13485, FDA QSR, and GD&T, plus experience with CAPA, risk management, and supplier management.

Qualifications

• Bachelor’s degree in Engineering, Science or Math or equivalent.
• 5+ years’ Quality Engineering in manufacturing or regulated environment.
• Knowledge of ISO 13485, FDA QSR, ISO 14971 and EU MDR concepts.

Responsibilities

• Investigate adverse events and device malfunctions per FDA/ISO.
• Support NCRs, supplier audits, and CAPA activities.
• Maintain supplier quality program and performance tracking.
• Lead internal and external audits and participate in PMS activities.
• Develop control plans, validation plans, and inspection procedures.
• Collect and report quality metrics and drive continuous improvement.

Skills

Statistical sampling

GD&T

Quality audits

Regulatory compliance

Root cause analysis

Education

Bachelor's degree in engineering/science/math

Tools

MS Office

Visio

Project

Minitab

Job description

Spectra Medical Devices, LLC in Wilmington, Massachusetts, is seeking a Senior Quality Engineer to lead quality programs in a medical device environment. You will manage supplier quality agreements, support customer complaints, and drive CAPA, NCR, and internal audit activities to ensure regulatory compliance.

The role requires a Bachelor’s degree and 5+ years in quality engineering, knowledge of ISO 13485, FDA QSR, and GD&T, plus experience with CAPA, risk management, and supplier management.