Regulated Quality Specialist — Healthcare & Med Devices

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

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.