ISO 13485 QMS Auditor - Chatsworth, CA (1099 Contractor)
Part Time • QE ( Chatsworth, CA)
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)
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)
Compensation: $30.00 - $40.00 per hour
About Us
Since 1984, Pro QC International goes above and beyond the traditional roles of quality control. We assist clients to put better quality products on the market by resolving quality and production related challenges and reducing supply chain risk and cost.
Pro QC offers solutions in over 88 countries. We manage our global operations from 18 Offices Worldwide. Our clients range from small start-ups to multinational companies in the Americas, Europe, Asia, the Middle East and Africa.
Pro QC offers solutions in over 88 countries. We manage our global operations from 18 Offices Worldwide. Our clients range from small start-ups to multinational companies in the Americas, Europe, Asia, the Middle East and Africa.
Join Our Team
We are always looking for talented candidates in Asia, Americas, Europe, Middle-East, and Africa.
At Pro QC, we value quality over quantity. We value professionalism, dependability, and teamwork.
We believe in building trusted partnerships that are earned through conscious efforts. In our strive for excellence, we are passionate about delivering quality solutions to organizations around the world. Leveraging an ever-expanding, interconnected group of people from diverse backgrounds, Pro QC offers an attractive and unique opportunity as part of a global family.
Our Vision: To nurture the trust of our customers and our team through dynamic interactions, creative supply chain solutions, and integrated partnership.
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