KH
Quality Specialist
Katalyst Healthcares & Life Sciences
🇺🇸 United States
Hybrid
3 months ago
- Regulatory Compliance
- Technical Writing
3 months ago
Not enough detail in this posting to match
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.
- 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.
Quality Specialist · Katalyst Healthcares & Life Sciences