Gandiv Insights LLC · 1 day ago
Supplier Quality Engineer
United States
Full-time
Remote
Senior Level
5+ years expGandiv Insights LLC is a company specializing in medical devices, and they are seeking an experienced Supplier Quality Engineer to support supplier quality management for medical device products. This role ensures suppliers meet FDA and ISO requirements, drives supplier performance improvement, and supports new supplier qualification and audits.
Information Technology & Services
Responsibilities
Manage supplier qualification, evaluation, and monitoring activities
Conduct supplier audits (on-site and remote) per ISO 13485 and FDA 21 CFR 820
Review and approve PPAP / First Article Inspection (FAI) documentation
Support incoming inspection and supplier-related nonconformances
Lead supplier CAPA, root cause analysis, and effectiveness checks
Support change control related to supplier or material changes
Collaborate with Purchasing, R&D, Manufacturing, and Quality teams
Support risk management activities for suppliers (FMEA, risk assessments)
Ensure supplier compliance during regulatory inspections
Qualification
Required
Bachelor's degree in Engineering or related technical field
5+ years of experience as a Supplier Quality Engineer in the medical device industry
Strong knowledge of ISO 13485, FDA 21 CFR 820, and supplier quality systems
Experience with supplier audits, CAPA, and change management
Strong documentation and communication skills
Company
Gandiv Insights LLC
Gandiv Insights is a leading professional services and staffing firm specializing in top-tier personnel and technical solutions across engineering, IT, non-IT, and healthcare sectors.
201-500 employees
Funding
Current Stage
Growth StageCompany data provided by crunchbase