Sr Engr, Supplier Quality
Core
Own, maintain, and improve the Supplier Quality Management System to ensure compliance with regulatory requirements and drive operational excellence for medical device manufacturing.
Role type
Senior Supplier Quality Systems Engineer
Builds
Supplier Quality Management System, audit programs, compliance documentation, and performance dashboards
Domain
Medical Device Manufacturing / Quality Systems
Deliverable
dashboards & analysis
Required skills
Supplier Quality Systems, supplier auditing, risk management, CAPA systems, process validation, regulatory compliance (FDA/ISO 13485), Lean Six Sigma, data analytics
Preferred skills
eQMS experience, Lean Six Sigma certification, data analytics tools
Technologies
eQMS, reporting systems, data analytics tools
Responsibilities
Lead Supplier Quality Review Board governance, develop and oversee the Supplier Audit Program, analyze supplier quality metrics and trends, drive continuous improvement projects using Lean/Six Sigma, provide guidance on quality procedures and compliance, partner with cross-functional teams on quality system alignment
Seniority
Senior, hands-on IC with mentorship