Quality Systems Specialist

Jobs › Danvers, MA › Quality Systems Specialist Insight Global Quality Systems Specialist Danvers, MA Apply Job Description Insight Global is hiring a Quality Systems Specialist / Field Actions Coordinator for our medical device client based out of the Greater Boston area. This individual will support the execution, coordination, and documentation of field actions and post‑market quality activities for commercially released medical devices. The role partners closely with Quality Systems, Regulatory Affairs, Operations, Field Service, Supply Chain, and Commercial teams to ensure field actions, including recalls, corrections, and customer notifications, are executed, documented, and closed in compliance with

FDA, ISO

13485, and internal Quality Management System (QMS) requirements. Day‑to‑Day Responsibilities

• Coordinate and support the end‑to‑end execution of field actions, including recalls, field safety corrective actions (FSCAs), product corrections, and customer notifications.
• Track field action milestones, deliverables, and closure activities, ensuring activities remain on schedule and compliant with internal and regulatory requirements.
• Serve as a primary quality coordination point for Field Service, Distribution, Operations, and Commercial partners during active field actions.
• Maintain accurate, audit‑ready documentation within the electronic QMS (eQMS), including field action records, change records, investigations, and CAPAs, as applicable.
• Execute administrative and document control activities, including routing documents for review, tracking approvals, following up on signatures, and ensuring proper version control.
• Support root cause investigations and corrective actions associated with post‑market events and field issues.
• Interface with Regulatory Affairs to support field action strategy, reporting requirements, and health authority notifications.
• Partner with Operations and Supply Chain to support product return, remediation, replacement, or rework activities tied to active field actions.
• Prepare and compile documentation to support FDA, ISO, and internal audits, ensuring inspection readiness for post‑market and field action processes.
• Coordinate cross‑functionally to resolve documentation gaps, administrative issues, and overdue records within the QMS.

Compensation:

$26/hr to $31/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.

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https://insightglobal.com/workforce-privacy-policy/. Skills and Requirements

• Bachelor's degree in Engineering, Life Sciences, or a related field
• 2-5+ years of experience in one or more of the following: Medical device Quality Systems, Commercial or Post‑Market Quality, or Field actions/complaints/recalls Working knowledge of:

• FDA 21 CFR

  Part 820
• ISO 13485
• Post‑market surveillance and field action processes
• Experience working within a regulated Quality Management System (eQMS)
• Strong organizational skills with the ability to track documentation, approvals, and multiple workstreams simultaneously
• Prior experience at medical device manufacturers (Class II or III)
• Familiarity with J&J MedTech quality frameworks
• Experience supporting global field actions
• Strong project management and cross‑functional coordination skills Active Filters Quality Systems Specialist Danvers, MA Clear All Apply