Quality Engineer - Medical Devices

Company Industry

Medical Device Manufacturing

Quality Engineer

Hybrid onsite 3 days/week in Danvers, MA

$45-60/hr

2

• Bachelor’s degree in Engineering or a scientific discipline
• 5+ years of experience in a regulated industry, preferably medical devices
• Experience in Commercial Quality Distribution, including demonstrated experience supporting or executing field actions, including recalls
• Ability to support field action execution over the next 6 months, with multiple active recalls
• Hands‑on experience with quality systems such as CAPA, nonconformance, change control, and audits
• Knowledge of medical device regulations (FDA QSR, ISO 13485, etc.)

• Experience supporting service and repair or commercial quality operations
• Exposure to global or multi‑site quality environments
• Experience with computer system validation or quality IT systems
• Familiarity with ISO 14971, EU MDR, or MDSAP
• Six Sigma or other continuous improvement methodology experience
• Master’s degree in engineering, science, or business

Insight Global is hiring a Quality Engineer for our medical device client in Danvers, MA. This role is onsite five days per week and will focus on supporting commercial quality distribution and field action execution, including active recalls, within a regulated medical device environment.

• Provide quality support for commercial distribution, service, and repair operations, including nonconformances, CAPAs, change controls, and escalations
• Support field action and recall execution, including coordination and tracking activities for multiple active field actions over the next six months
• Oversee quality activities related to finished goods and material that are approved and released to distribution warehouses
• Partner with operations and supply chain teams to ensure compliance with medical device quality systems and regulatory requirements
• Support internal and external audits and inspections related to distribution, service, and field action activities
• Help implement and continuously improve quality processes, SOPs, and systems aligned with industry standards
• Identify quality risks, support issue resolution, and drive continuous improvement initiatives
• Collaborate cross‑functionally with quality, operations, supply chain, and commercial teams to define and execute quality and field action strategies

$45.00/hr to $60.00/hr exact compensation may vary based on several factors, including skills, experience, and education. Employees in this role will enjoy a comprehensive benefits package starting on day one of employment, including options for medical, dental, and vision insurance. Eligibility to enroll in the 401(k) retirement plan begins after 90 days of employment. Additionally, employees in this role will have access to paid sick leave and other paid time off benefits as required under the applicable law of the worksite location.