Senior Supplier Quality Engineer
Core
Partner with Contract Manufacturers (CMs), Original Equipment Manufacturers (OEMs), and critical suppliers to ensure quality, compliance, and performance of externally manufactured medical device products and components.
Role type
Senior Supplier Quality Engineer (Medical Devices)
Builds
Externally manufactured medical device products and components
Domain
Medical Devices / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Supplier quality systems, supplier qualification, supplier audits, supplier performance management, risk assessment, validation, root cause analysis, New Product Development (NPD) support, regulatory requirements interpretation, corrective and preventive actions (CAPA), Good Manufacturing Practices (GMP), ISO 13485, 21 CFR Part 820
Preferred skills
Lead Auditor certification, ASQ certification, regulated industry experience, product transfers, process validation, design transfer, supplier onboarding, continuous improvement initiatives
Technologies
ISO 13485, 21 CFR Part 820, GMP
Responsibilities
Manage quality oversight of strategic Contract Manufacturers (CMs), Original Equipment Manufacturers (OEMs), and designated suppliers; Lead supplier quality activities for product and process changes including risk assessment and validation; Monitor supplier performance metrics and drive corrective actions; Plan and conduct supplier audits for GMP and regulatory compliance; Partner with R&D, Regulatory Affairs, and Operations to ensure product requirements are met; Investigate supplier-related nonconformances and facilitate root cause analysis; Provide Supplier Quality support for New Product Development (NPD) activities; Define and maintain receiving inspection requirements and quality documentation.
Seniority
Senior, hands-on IC