Senior Quality Engineer - Medical Device | ISO 13485 Lead

Mount Kemble Search Group; Danvers (MA); On-site; USD 95,000 - 120,000; Full time

Benefits offered by this job

401(k) with Company Match

Paid Time Off and 9 Paid Holidays

Tuition Reimbursement

Health Reimbursement

Life Insurance

Job summary

A leading recruitment firm is seeking a Senior Quality Engineer to drive quality excellence in Danvers, MA. The ideal candidate will have extensive experience in medical device manufacturing, leading quality systems, and continuous improvement initiatives. This direct hire position offers a competitive salary between $95,000 and $120,000, along with comprehensive benefits. Occasional travel may be required to Fiskdale, MA.

Qualifications

• 3+ years of experience in Quality Engineering, preferably in a medical device environment.
• Strong working knowledge of ISO 9001 and ISO 13485 standards.
• Hands-on experience in injection molding environments is preferred.

Responsibilities

• Develop and maintain Quality Management System elements.
• Lead quality improvement initiatives.
• Support new product introductions and APQP processes.

Skills

Quality Engineering

ISO 13485

Continuous Improvement

GD&T

Quality Tools (FMEAs, Control Plans)

Communication Skills

Education

Bachelor’s degree in a technical or engineering field

Tools

SolidWorks

iQMS

Vision Inspection Systems (QVI OGP SmartScope)

Job description

A leading recruitment firm is seeking a Senior Quality Engineer to drive quality excellence in Danvers, MA. The ideal candidate will have extensive experience in medical device manufacturing, leading quality systems, and continuous improvement initiatives. This direct hire position offers a competitive salary between $95,000 and $120,000, along with comprehensive benefits. Occasional travel may be required to Fiskdale, MA.