Senior Quality Engineer - Medical Devices (Onsite)

Elevaris Medical Devices Inc.; Wilmington (MA); On-site; USD 115,000 - 130,000; Full time

Job summary

Elevaris Medical Devices is a leading developer and manufacturer of precision medical devices and related products. The Senior Quality Engineer will maintain supplier quality programs, support customer complaints, investigations, CAPA and internal audits in an FDA/ISO regulated environment.

The role is onsite in Wilmington, MA, involving Gage R&R, validation activities, and continuous improvement initiatives to ensure cGMP compliance and strong quality metrics across the organization.

Qualifications

• Bachelor’s degree in engineering/science/math with 5+ years in quality engineering in manufacturing or FDA/ISO regulated environment.
• Knowledge of statistical sampling and analysis.
• Strong knowledge of ISO 13485, FDA QSR, ISO 14971 and EU MDR concepts.
• Ability to read blueprints and GD&T.
• Technical writing experience.
• Experience performing quality audits and Six Sigma/Lean methods.

Responsibilities

• Investigate adverse events/incidents and report per FDA/regulatory requirements.
• Support nonconforming material and customer complaints; perform investigations and dispositions.
• Coordinate supplier corrective actions and follow-up on CAPA activities.
• Support risk management activities and internal/external audits and inspections.
• Perform supplier qualification, audits and scorecards for supplier performance.
• Collect and report quality metrics; identify opportunities for continuous improvement.

Skills

Statistical analysis

Quality systems

GD&T

Technical writing

Six Sigma/Lean

Education

Bachelor’s degree in Engineering, Science or Math

Tools

MS Office

Visio

Project

Minitab

Job description

Elevaris Medical Devices is a leading developer and manufacturer of precision medical devices and related products. The Senior Quality Engineer will maintain supplier quality programs, support customer complaints, investigations, CAPA and internal audits in an FDA/ISO regulated environment.

The role is onsite in Wilmington, MA, involving Gage R&R, validation activities, and continuous improvement initiatives to ensure cGMP compliance and strong quality metrics across the organization.