Quality Specialist

Katalyst Healthcares and Life Sciences

Job Description:

Quality Specialist with experience in Healthcare, Pharmaceutical, Medical Device, or Regulated Distribution environments to support Quality Management System (QMS) operations, supplier quality programs, quality agreements, SOP development, and regulatory compliance activities.
The ideal candidate will have strong knowledge of FDA 21 CFR Part 211, ISO 13485, supplier quality processes, and document-controlled QMS environments.
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/orISO 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.

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Vacancy posted 5 hours ago

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