Quality Engineer

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 $50.00/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.

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to HR@insightglobal.com.To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.

-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

-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

Benefit packages for this role will start on the 1st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.