Quality Specialist

Katalyst CRO; Los Angeles (CA); On-site; USD 85,000 - 110,000; Full time

Job summary

Katalyst CRO is seeking a Quality Specialist with experience in Healthcare, Pharmaceutical, Medical Device, or Regulated Distribution to support QMS operations, supplier quality programs, and regulatory compliance activities.

The ideal candidate will understand FDA 21 CFR Part 211, ISO 13485, supplier quality processes, and document-controlled QMS environments, while collaborating with cross-functional teams to maintain audit-ready records.

Qualifications

• 3–5+ years in Quality or Regulated environments.
• Experience in Pharma, Medical Device, Healthcare, or Life Sciences.
• Knowledge of FDA 21 CFR Part 211 and ISO 13485.
• Experience with Supplier Quality, Quality Agreements, and Questionnaires.
• Experience authoring SOPs in a document-controlled QMS.
• DEA Controlled Substance compliance experience.
• Experience with supplier audits and customer audits.
• Audit-ready documentation per ALCOA+.

Responsibilities

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

Skills

Quality Assurance

Regulatory Compliance

Documentation & Writing

Cross-functional Collaboration

Audit Support

Education

ASQ CQE/CQA certification

Tools

MasterControl

Job description

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/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.