Quality Specialist

Roles & Responsibilities

• Support Quality Management System (QMS) activities and regulatory compliance initiatives.
• Manage customer and supplier quality questionnaires and supplier qualification processes.
• Review and support Quality Agreements, supplier contracts, and compliance documentation.
• Author, revise, and maintain SOPs and controlled quality documents.
• Support controlled substance compliance processes and regulatory requirements.
• Ensure alignment with FDA, DEA, ISO 13485, and internal quality standards.
• Maintain audit-ready documentation and records following ALCOA+ principles.
• Collaborate with Quality, Regulatory, Operations, Legal, and Compliance teams.

Requirements

• 3-5+ years of experience in Quality, Compliance, QA, or Regulated Distribution environments.
• Experience in Pharmaceutical, Medical Device, Healthcare, or Life Sciences industries.
• Knowledge of FDA 21 CFR Part 211 and/or ISO 13485 requirements.
• Experience with Supplier Quality, Quality Agreements, and Quality Questionnaires.
• Experience authoring and maintaining SOPs.
• Experience working within a document-controlled QMS environment.
• Strong technical writing, documentation, and audit support skills.
• DEA Controlled Substance compliance experience.
• Experience supporting supplier/customer audits.
• Experience with MasterControl or other eQMS platforms.
• ASQ CQE, CQA, or related certifications.