Support medical device clients with quality systems training, administering LMS platforms, and managing training workflows. Strong understanding of Quality Systems and FDA regulatory requirements required. Excellent attention to detail and organizational skills needed.
Key Highlights
Key Responsibilities
Technical Skills Required
Benefits & Perks
Nice to Have
Job Description
JOB DESCRIPTION
Insight Global is seeking a Quality Systems Training Specialist to support our Medical Device client. This consultant will sit remotely or onsite at the clients facility in Danvers, MA.
Day to day will consist of the following:
-Administer and maintain the Learning Management System (LMS) to ensure accurate training records across the business
-Act as training coordinator for change requests when required.
-Manage and resolve training system tickets in a timely manner.
-Provide end-to-end process support by collaborating with users to ensure successful completion of training assignments.
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-Generate and deliver reports for internal and external inspections and audits.
-Communicate and escalate issues to the next management level as needed.
-Execute additional activities as directed by the Training Leader to support remediation efforts.
Compensation: $6-10/hr (USD) Exact compensation may vary based on several factors, including skills, experience, and education
REQUIRED SKILLS AND EXPERIENCE
-2+ years experience administering LMS platforms (e.g., ComplianceWire, Cornerstone, or similar). -Strong understanding of Quality Systems and FDA regulatory requirements.
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-Ability to manage training workflows and documentation in a regulated environment.
-Excellent attention to detail, organizational skills, and ability to meet strict deadlines.
-Proficiency in Microsoft Office Suite (Excel, Word, PowerPoint).
NICE TO HAVE SKILLS AND EXPERIENCE
-Prior experience in medical device or pharmaceutical industry.
-Familiarity with Windchill or other document management systems.
-Experience supporting audit remediation projects (FDA, EU MDR, etc.).
-Knowledge of Good Documentation Practices (GDP).
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