Job Responsibilities:

Seeking ISO 13485 Auditor with European MDR, but only for Class 1 Medical Devices

Provides timely, detailed reports and photographic evidence.

Industry Experience:

Proven experience conducting internal (second-party) audits and supplier audits in compliance with ISO 13485, ISO 9001, FDA 21 CFR Part 820, EU MDR, and GMP standards.

Demonstrated expertise in evaluating both new and existing suppliers for quality system compliance, risk management, and regulatory readiness.

Skilled in performing and reviewing equipment, product, and process validation and verification (V&V) activities in accordance with medical device regulatory expectations.

Strong understanding of quality system documentation, CAPA processes, and audit follow-up to ensure effective closure of nonconformities and continuous improvement.

Certifications Required:

Certified ISO 13485:2016 Lead Auditor with comprehensive training in quality management system requirements specific to medical devices.

Job type: 1099 contract

Project Duration: 2 days per audit. (CURRENT PROJECT) NOTE: in a 1099 Contract, Project duration varies project to project.

Shift Hours: 1st Shift (CURRENT PROJECT) NOTE: in a 1099 Contract, duration varies from project to project.

Ability to commute to Chatsworth, CA 91311 (and other Chatsworth areas after current Project completion in future)