What are the responsibilities and job description for the Quality Engineer - Medical Devices position at Insight Global?
Company Industry: Medical Device Manufacturing
Title: Quality Engineer
Location: Hybrid onsite 3 days/week in Danvers, MA
Pay Range: $40-55/hr
Openings: 2
Required Skills & Experience
-Bachelor’s degree in Engineering or a scientific discipline
-5 years of experience in a regulated industry, preferably medical devices
-Hands‑on experience with quality systems such as CAPA, nonconformance, change control, and audits
-Knowledge of medical device regulations (FDA QSR, ISO 13485, etc.)
-Strong communication skills and ability to work cross‑functionally in a fast‑changing environment
-Detail‑oriented, self‑directed, and comfortable managing multiple priorities
Nice to Have Skills & Experience
-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
Job Description
Insight Global is hiring a Quality Engineer for our medical device client in Danvers, MA. This role will onsite 5 days per week.
Day-to-Day
-Provide quality support for service and repair operations, including nonconformances, CAPAs, change controls, and escalations
-Partner with operations teams to ensure compliance with medical device quality systems and regulatory requirements
-Support internal and external audits and inspections related to service and repair activities
-Help implement and 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
Compensation:
$45.00/hr to $55.00/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.
Salary : $40 - $55